Chrysalis Intelligence · Sponsors · Medtronic Sofamor Danek USA, Inc.

Medtronic Sofamor Danek USA, Inc.

Memphis, TN, US · 38 510(k) clearances · 48 PMAs · 50 recalls

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Total clearances
38
2020-01-10 → 2026-07-17
Last 12 months
9
Product codes
9
Most recent
2026-07-17
Name variants in FDA filings: Medtronic Sofamor Danek USA, Inc. / Medtronic Sofamor Danek USA
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 12 2026-07-17
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 11 2026-04-21
OLO Orthopedic Stereotaxic Instrument Class II Neurology 6 2023-05-26
NKG Posterior Cervical Screw System Class II Orthopedic 3 2026-01-21
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 2 2026-06-05
OUR Sacroiliac Joint Fixation Class II Orthopedic 1 2025-06-26
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Class II Orthopedic 1 2024-10-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Class II Orthopedic 1 2023-06-15
NQP Posterior Metal/Polymer Spinal System, Fusion Class II Orthopedic 1 2021-01-15
Class III

PMA approvals (48)

Total PMA records
48
Originals + supplements
Distinct product codes
3
First decision
2020-02-04
Most recent
2026-07-28
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-28 P000058-S099 Infuse TM Bone Graft/Medtronic lnterbody Fusion Device Normal 180 Day Track NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2026-07-28 P000054-S078 Infuse™ Bone Graft Normal 180 Day Track MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2026-03-19 P000058-S098 INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2026-03-19 P000054-S077 INFUSE® Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2026-02-24 P000058-S097 INFUSE Bone Graft/Medtronic Interbody Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2026-02-24 P000054-S076 INFUSE Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2026-02-13 P000058-S096 Infuse Bone Graft Panel Track NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2025-03-19 P000058-S094 INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2025-03-19 P000054-S074 INFUSE® Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2024-11-06 P000058-S093 INFUSE™ Bone Graft/Medtronic Interbody Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2024-11-06 P000054-S073 INFUSE™ Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2024-08-09 P090029-S021 Prestige LP (R) Cervical Disc 30-Day Notice MJO — —
2024-05-01 P090029-S020 Prestige LP (R) Cervical Disc 30-Day Notice MJO — —
2024-02-21 P090029-S018 Prestige LP Cervical Disc Normal 180 Day Track No User Fee MJO — —
2023-10-26 P090029-S019 Prestige LP® Cervical Disc 30-Day Notice MJO — —
2023-10-06 P000058-S091 INFUSE™ Bone Graft/Medtronic Interbody Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2023-10-06 P000054-S071 INFUSE™ Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2023-08-25 P000058-S088 Infuse Bone Graft Normal 180 Day Track NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2023-08-21 P000058-S090 INFUSE™ Bone Graft, Medtronic Interbody Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2023-08-21 P000058-S089 INFUSE™ Bone Graft, Medtronic Interbody Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2023-08-21 P000054-S070 INFUSE™ Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2023-08-21 P000054-S069 INFUSE™ Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2023-05-24 P090029-S017 Prestige LP® Cervical Disc 30-Day Notice MJO — —
2022-08-09 P000058-S087 Infuse™ Bone Graft/Medtronic Interbody Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2022-08-09 P000054-S068 Infuse™ Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2022-06-09 P000054-S067 Infuse Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2022-06-08 P000058-S086 Infuse Bone Graft/Medtronic Interbody Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2022-02-18 P000058-S081 Infuse Bone Graft/Medtronic Interbody Fusion Device Normal 180 Day Track NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2022-02-18 P000054-S062 Infuse Bone Graft Normal 180 Day Track MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2022-02-17 P000058-S085 INFUSE™ BoneGraft/Medtronic lnterbody Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2022-02-17 P000054-S066 INFUSE™ Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2021-11-08 P000058-S079 Infuse Bone Graft/Medtronic Interbody Fusion Device 135 Review Track For 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2021-11-08 P000054-S060 Infuse Bone Graft 135 Review Track For 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2021-04-05 P000058-S084 INFUSE Bone Graft/Medtronic Interbody Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2021-04-05 P000054-S065 INFUSE Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2021-02-05 P000058-S083 Infuse Bone Graft/Medtronic Interbody Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2021-02-05 P000054-S064 Infuse Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2020-12-30 P000058-S080 Infuse Bone Graft/Medtronic Interbody Fusion Device 135 Review Track For 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2020-12-30 P000054-S061 Infuse Bone Graft 135 Review Track For 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2020-12-01 P090029-S015 PRESTIGE LP Cervical Disc 30-Day Notice MJO — —
2020-08-27 P000058-S082 Infuse Bone Graft/Medtronic Interbody Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2020-08-27 P000054-S063 Infuse Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2020-07-10 P000058-S078 Infuse Bone Graft/Medtronic Interbody Fusion Device 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2020-07-10 P000054-S059 Infuse Bone Graft 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
2020-04-15 P090029-S014 PRESTIGE LP Cervical Disc 30-Day Notice MJO — —
2020-03-06 P090029-S013 Prestiege LP Cervical Disc - Two-Level Normal 180 Day Track No User Fee MJO — —
2020-02-04 P000058-S073 Infuse Bone Graft/Medtronic Interbody Fusion Device 135 Review Track For 30-Day Notice NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown
2020-02-04 P000054-S054 Infuse Bone Graft 135 Review Track For 30-Day Notice MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown
Safety

Recalls (50)

Class I (serious)
0
Risk of injury / death
Total recalls
50
Currently ongoing
35
Most recent
2025-09-16
DateSeverityStatusRecall # ProductCodeReason
2025-09-16 Class II Ongoing Z-0580-2026 Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073… — Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Theref…
2023-09-26 Class II Ongoing Z-0167-2024 Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110IN… — Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed acc…
2023-09-26 Class II Ongoing Z-0166-2024 Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix — Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed acc…
2023-09-26 Class II Ongoing Z-0165-2024 Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix — Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed acc…
2023-09-26 Class II Ongoing Z-0164-2024 Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix — Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed acc…
2023-09-26 Class II Ongoing Z-0163-2024 Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix — Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed acc…
2023-09-26 Class II Ongoing Z-0162-2024 Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix — Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed acc…
2023-09-26 Class II Ongoing Z-0161-2024 Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix — Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed acc…
2023-07-31 Class II Ongoing Z-2524-2023 Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile. — The incorrect product labeling was applied to the product indicating the wrong size of product.
2023-07-12 Class II Ongoing Z-2363-2023 CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K — Incorrect Laser Marking - Solera Awl Tip Tap
2023-06-06 Class II Ongoing Z-2123-2023 Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant ki… — There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices …
2023-06-06 Class II Ongoing Z-2122-2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant — There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices …
2023-06-06 Class II Ongoing Z-2121-2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant — There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices …
2023-06-06 Class II Ongoing Z-2120-2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant — There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices …
2023-06-06 Class II Ongoing Z-2119-2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant — There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices …
2023-06-06 Class II Ongoing Z-2118-2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant — There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices …
2023-06-06 Class II Ongoing Z-2117-2023 Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant — There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices …
2023-02-16 Class II Ongoing Z-1413-2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization… — Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
2023-02-16 Class II Ongoing Z-1412-2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization… — Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
2023-02-16 Class II Ongoing Z-1411-2023 INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT402… — Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
2023-02-16 Class II Ongoing Z-1410-2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization… — Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
2023-02-16 Class II Ongoing Z-1409-2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization… — Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
2023-02-08 Class II Ongoing Z-1334-2023 Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF … — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in…
2023-02-08 Class II Ongoing Z-1333-2023 Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c)… — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in…
2023-02-08 Class II Ongoing Z-1332-2023 Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206… — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in…
2023-02-08 Class II Ongoing Z-1331-2023 Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T… — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in…
2023-02-08 Class II Ongoing Z-1330-2023 Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101… — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in…
2023-02-08 Class II Ongoing Z-1329-2023 Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S450… — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in…
2023-02-08 Class II Ongoing Z-1328-2023 Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20C… — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in…
2023-02-08 Class II Ongoing Z-1327-2023 Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2… — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in…
2023-02-08 Class II Ongoing Z-1326-2023 Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND L… — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in…
2023-02-08 Class II Ongoing Z-1325-2023 Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON… — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in…
2023-02-08 Class II Ongoing Z-1324-2023 Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115… — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in…
2023-02-08 Class II Ongoing Z-1323-2023 Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S4310… — Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in…
2021-11-19 Class II Ongoing Z-1574-2023 Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in sp… — Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the in…
2021-09-02 Class II Terminated Z-0086-2022 Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm — Engraving on implants may not match what is listed on the pouch labels.
2021-09-02 Class II Terminated Z-0085-2022 Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm — Engraving on implants may not match what is listed on the pouch labels.
2021-04-27 Class II Terminated Z-1797-2021 Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spina… — Product is impacted by a thread profile defect due to a manufacturing issue.
2021-03-17 Class II Terminated Z-1440-2021 Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608… — The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
2021-03-17 Class II Terminated Z-1439-2021 Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208… — The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
2020-06-08 Class II Terminated Z-2695-2020 Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Prod… — Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08 Class II Terminated Z-2694-2020 Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Prod… — Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08 Class II Terminated Z-2693-2020 Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Pro… — Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08 Class II Terminated Z-2692-2020 Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Pro… — Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08 Class II Terminated Z-2691-2020 Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Pro… — Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-06-08 Class II Terminated Z-2690-2020 Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Prod… — Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
2020-04-24 Class II Terminated Z-2391-2020 Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone… — Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implanta…
2020-04-24 Class II Terminated Z-2390-2020 Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone… — Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implanta…
2020-04-24 Class II Terminated Z-2389-2020 Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bo… — Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implanta…
2020-03-26 Class II Terminated Z-1941-2020 VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 — Nonconforming product; length of the product measured shorter than the labeled length.
Filings

All 510(k) clearances (38)

Date K-number Device Code Class Specialty
2026-07-17 K253011 Catalyft PL Expandable Interbody System MAX Class II Orthopedic
2026-07-14 K261020 Symmetrix™ L Spinal System MAX Class II Orthopedic
2026-06-05 K253656 OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System GEI Class II General, Plastic Surgery
2026-04-21 K260216 CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System NKB Class II Orthopedic
2026-01-21 K254165 Infinity™ OCT System NKG Class II Orthopedic
2026-01-07 K253941 CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) NKB Class II Orthopedic
2025-10-24 K253335 CD Horizon™ Spinal System NKB Class II Orthopedic
2025-10-24 K253129 Infinity™ OCT System NKG Class II Orthopedic
2025-09-04 K251444 Endoskeleton™ Interbody Systems MAX Class II Orthopedic
2025-06-26 K251395 The Rialto™ SI Fusion System OUR Class II Orthopedic
2025-04-22 K250669 Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology MAX Class II Orthopedic
2024-10-28 K241992 Catalyft™ LS Expandable Interbody System OVD Class II Orthopedic
2024-10-23 K243007 CD Horizon™ Spinal System NKB Class II Orthopedic
2024-03-27 K233951 CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) NKB Class II Orthopedic
2024-02-28 K233830 OsteoCool™ 2.0 RF Ablation System GEI Class II General, Plastic Surgery
2023-08-16 K232141 CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) NKB Class II Orthopedic
2023-06-15 K231090 Zevo Anterior Cervical Plate System KWQ Class II Orthopedic
2023-05-26 K231184 CD Horizon™ Spinal System OLO Class II Neurology
2023-01-11 K223764 INFINITY OCT System NKG Class II Orthopedic
2022-12-16 K223153 Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology MAX Class II Orthopedic
2022-10-04 K221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM NKB Class II Orthopedic
2022-09-29 K222383 Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition OLO Class II Neurology
2022-05-25 K221180 Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments OLO Class II Neurology
2022-04-12 K214010 Anteralign Spinal System with Titan nanoLOCK Surface Technology MAX Class II Orthopedic
2022-02-09 K214011 Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers OLO Class II Neurology
2021-12-08 K212524 Anteralign Spinal System with Titan nanoLOCK Surface Technology MAX Class II Orthopedic
2021-11-19 K212653 Catalyft LS Expandable Interbody System MAX Class II Orthopedic
2021-07-21 K211958 CD Horizon Spinal System NKB Class II Orthopedic
2021-06-09 K211441 Navigated Anterolateral Disc Prep Instruments OLO Class II Neurology
2021-05-26 K211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System MAX Class II Orthopedic
2021-05-24 K210425 Catalyft PL Expandable Interbody System MAX Class II Orthopedic
2021-01-15 K203678 CD HORIZON™ Spinal System NQP Class II Orthopedic
2020-12-08 K203291 CD Horizon Spinal System Instruments OLO Class II Neurology
2020-09-10 K201407 CD Horizon™ Spinal System NKB Class II Orthopedic
2020-09-08 K202328 CD Horizon Spinal System NKB Class II Orthopedic
2020-03-23 K191788 CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System MAX Class II Orthopedic
2020-01-22 K192502 Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus MAX Class II Orthopedic
2020-01-10 K193011 CD Horizon™ Fenestrated Screw Set NKB Class II Orthopedic
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence