Chrysalis Intelligence · Sponsors · Alphatec Spine, Inc.

Alphatec Spine, Inc.

Carlsnad, CA, US · 49 510(k) clearances · 35 recalls

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Total clearances
49
2020-05-21 → 2026-07-14
Last 12 months
7
Product codes
17
Most recent
2026-07-14
Name variants in FDA filings: Alphatec Spine, Inc. / Alphatec Spine
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 2025-02-03
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 7 2026-07-14
OLO Orthopedic Stereotaxic Instrument Class II Neurology 6 2026-02-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Class II Orthopedic 5 2025-08-28
GWF Stimulator, Electrical, Evoked Response Class II Neurology 3 2026-01-11
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Class II Orthopedic 3 2025-09-03
ODP Intervertebral Fusion Device With Bone Graft, Cervical Class II Orthopedic 2 2025-07-03
NKG Posterior Cervical Screw System Class II Orthopedic 2 2020-12-18
SIN Automated Intraoperative Spinal Rod Bending System Class II Orthopedic 1 2026-06-25
OWI Bone Fixation Cerclage, Sublaminar Class II Orthopedic 1 2026-03-25
— — — — 1 2025-03-04
OWB — — — 1 2024-05-22
MQP Spinal Vertebral Body Replacement Device Class II Orthopedic 1 2023-10-06
PML Bone Cement, Posterior Screw Augmentation Class II Orthopedic 1 2022-12-20
PDQ Neurosurgical Nerve Locator Class II Ear, Nose, Throat 1 2022-09-23
LLZ System, Image Processing, Radiological Class II Radiology 1 2021-10-29
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Class II Orthopedic 1 2020-12-18
Safety

Recalls (35)

Class I (serious)
0
Risk of injury / death
Total recalls
35
Currently ongoing
6
Most recent
2026-01-02
DateSeverityStatusRecall # ProductCodeReason
2026-01-02 Class II Ongoing Z-1343-2026 ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471;… — Due a design issue where the navigated array connection geometry is incorrect.
2026-01-02 Class II Ongoing Z-1342-2026 ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179;… — Due a design issue where the navigated array connection geometry is incorrect.
2024-12-15 Class II Ongoing Z-1065-2025 Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 d… — Complaints have been received regarding post-operative implant collapse.
2024-01-26 Class II Ongoing Z-1182-2024 IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x… — Due to reports of intraoperative graft bolt implantation breakages.
2023-07-07 Class II Ongoing Z-2475-2023 LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, T… — Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set p…
2022-09-14 Class II Ongoing Z-0196-2023 Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A … — Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.
2021-04-26 Class II Terminated Z-1827-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1826-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1825-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1824-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1823-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1822-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1821-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1820-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1819-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1818-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1817-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1816-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1815-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1814-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1813-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1812-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1811-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1810-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1809-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1808-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1807-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1806-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (0… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1805-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (0… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1804-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (0… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1803-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (0… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1802-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (0… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1801-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (0… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1800-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (0… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
2021-04-26 Class II Terminated Z-1799-2021 Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (0… — There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope…
Filings

All 510(k) clearances (49)

Date K-number Device Code Class Specialty
2026-07-14 K261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System NKB Class II Orthopedic
2026-06-25 K253216 IntraOp Alignment System; CONTOUR3D Bending System SIN Class II Orthopedic
2026-03-25 K253615 Invictus Bands System OWI Class II Orthopedic
2026-02-19 K252597 Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) OLO Class II Neurology
2026-01-11 K252842 SafeOp 3: Neural Informatix System GWF Class II Neurology
2025-09-03 K251575 IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System OVD Class II Orthopedic
2025-08-28 K251965 Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) KWQ Class II Orthopedic
2025-07-03 K251080 IdentiTi II Cervical Interbody System ODP Class II Orthopedic
2025-03-04 K243461 Calibrate Interbody Systems — — —
2025-02-03 K241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer MAX Class II Orthopedic
2024-10-04 K242364 IdentiTi™ II Interbody System MAX Class II Orthopedic
2024-09-20 K242147 Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System MAX Class II Orthopedic
2024-06-21 K241519 Invictus® Small Stature Spinal Fixation System NKB Class II Orthopedic
2024-06-06 K240951 Invictus Robotic Navigation Instruments OLO Class II Neurology
2024-05-22 K240199 IntraOp Alignment System OWB — —
2024-04-19 K234092 SafeOp 3: Neural Informatix Systeem GWF Class II Neurology
2024-02-22 K233640 Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System KWQ Class II Orthopedic
2023-11-02 K232345 ATEC Posterior Navigated Disc Prep Instruments OLO Class II Neurology
2023-10-13 K232504 Calibrate CCX Interbody System MAX Class II Orthopedic
2023-10-06 K232173 Ascend VBR System, Ascend NanoTec VBR System MQP Class II Orthopedic
2023-10-06 K232044 Invictus Robotic Navigation Instruments OLO Class II Neurology
2023-09-27 K232275 Invictus® Spinal Fixation System NKB Class II Orthopedic
2023-09-25 K232097 IdentiTi ALIF Interbody Systems OVD Class II Orthopedic
2023-09-08 K232413 Fusion Robotic Navigation System OLO Class II Neurology
2023-07-13 K231438 Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System MAX Class II Orthopedic
2023-05-09 K230721 ATEC Lateral Plate System KWQ Class II Orthopedic
2023-03-29 K223611 Calibrate LTX Interbody System MAX Class II Orthopedic
2023-03-23 K223765 ATEC Lateral Navigation Instruments OLO Class II Neurology
2022-12-20 K221926 Invictus® Bone Cement, Invictus Spinal Fixation System PML Class II Orthopedic
2022-11-18 K222455 Calibrate LTX Interbody System MAX Class II Orthopedic
2022-11-17 K222973 IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem ODP Class II Orthopedic
2022-10-07 K222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System MAX Class II Orthopedic
2022-09-23 K221821 ATEC IOM Accessory Instruments PDQ Class II Ear, Nose, Throat
2022-06-09 K220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System MAX Class II Orthopedic
2022-04-04 K214006 Invictus® Spinal Fixation System NKB Class II Orthopedic
2022-03-09 K213849 SafeOp 2: Neural Informatix System GWF Class II Neurology
2021-12-15 K213443 Insignia™ Anterior Cervical Plate System KWQ Class II Orthopedic
2021-12-10 K213460 Invictus Spinal Fixation System NKB Class II Orthopedic
2021-10-29 K211987 ATEC Alignment App LLZ Class II Radiology
2021-09-22 K211805 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System MAX Class II Orthopedic
2021-08-10 K211873 PSX Interbody System MAX Class II Orthopedic
2021-04-09 K203742 IdentiTi ALIF Standalone Interbody System OVD Class II Orthopedic
2020-12-18 K203125 Invictus™ OCT Spinal Fixation System NKG Class II Orthopedic
2020-12-18 K202812 IdentiTi Cervical Standalone Interbody System OVE Class II Orthopedic
2020-11-23 K203056 Invictus™ Spinal Fixation System NKB Class II Orthopedic
2020-11-06 K202587 ATEC Lateral Interbody System MAX Class II Orthopedic
2020-10-15 K202327 Invictus™ OsseoScrew® System NKB Class II Orthopedic
2020-05-22 K200936 Invictus™ CT Spinal Fixation System NKG Class II Orthopedic
2020-05-21 K200995 Insignia™ Anterior Cervical Plate System KWQ Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence