Chrysalis Intelligence · Sponsors · SeaSpine Orthopedics Corporation

SeaSpine Orthopedics Corporation

Carlsbad, CA, US · 41 510(k) clearances · 9 recalls

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Total clearances
41
2020-02-13 → 2026-07-01
Last 12 months
1
Product codes
10
Most recent
2026-07-01
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 15 2026-07-01
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 6 2025-06-18
MQV Filler, Bone Void, Calcium Compound Class II Orthopedic 5 2024-09-25
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Class II Orthopedic 5 2023-11-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Class II Orthopedic 4 2021-09-01
OLO Orthopedic Stereotaxic Instrument Class II Neurology 2 2025-04-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Class II Orthopedic 1 2023-02-03
OWI Bone Fixation Cerclage, Sublaminar Class II Orthopedic 1 2020-08-05
NKG Posterior Cervical Screw System Class II Orthopedic 1 2020-03-25
PGM Growing Rod System Class II Orthopedic 1 2020-02-13
Safety

Recalls (9)

Class I (serious)
0
Risk of injury / death
Total recalls
9
Currently ongoing
9
Most recent
2025-11-17
DateSeverityStatusRecall # ProductCodeReason
2025-11-17 Class II Ongoing Z-0937-2026 Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Naviga… — The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatib…
2025-08-06 Class II Ongoing Z-2554-2025 Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System — Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioni…
2024-10-29 Class II Ongoing Z-0752-2025 Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001… — Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
2024-10-29 Class II Ongoing Z-0751-2025 Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79… — Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
2024-06-04 Class II Ongoing Z-2357-2024 Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Descrip… — Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
2024-05-17 Class II Ongoing Z-2235-2024 Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product D… — Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
2024-05-17 Class II Ongoing Z-2234-2024 Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product D… — Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
2024-02-28 Class II Ongoing Z-1620-2024 Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, … — Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw…
2024-02-15 Class II Ongoing Z-1605-2024 Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformi… — Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Filings

All 510(k) clearances (41)

Date K-number Device Code Class Specialty
2026-07-01 K253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy MAX Class II Orthopedic
2025-06-18 K250908 Virata Spinal Fixation System NKB Class II Orthopedic
2025-04-02 K243659 FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments OLO Class II Neurology
2024-09-25 K242273 Cove Putty, OsteoCove Putty MQV Class II Orthopedic
2024-06-20 K241466 Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System MAX Class II Orthopedic
2024-04-26 K240566 Reef L Interbody System; WaveForm L Interbody System MAX Class II Orthopedic
2024-04-19 K232566 NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System NKB Class II Orthopedic
2024-01-12 K233694 Meridian Interbody System; WaveForm A Interbody System MAX Class II Orthopedic
2023-11-28 K233414 Shoreline ACS Interbody System; Shoreline RT Interbody System OVE Class II Orthopedic
2023-09-27 K232668 Cove Strip, OsteoCove Strip MQV Class II Orthopedic
2023-09-14 K231030 Cove Putty, OsteoCove Putty MQV Class II Orthopedic
2023-08-21 K230486 Cove Strip MQV Class II Orthopedic
2023-02-03 K220296 Manta Ray TDF Spacer ODP Class II Orthopedic
2022-12-09 K222753 SeaSpine 7D Navigation Instruments OLO Class II Neurology
2022-11-07 K222732 WaveForm A Interbody System MAX Class II Orthopedic
2022-09-07 K222110 Mariner RDX System NKB Class II Orthopedic
2022-05-10 K220711 SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System MAX Class II Orthopedic
2022-05-04 K213420 WaveForm L System, WaveForm TO System, WaveForm TA System MAX Class II Orthopedic
2021-12-14 K212904 SeaSpine WaveForm C Interbody System OVE Class II Orthopedic
2021-12-09 K213359 SeaSpine WaveForm, C Interbody System OVE Class II Orthopedic
2021-09-21 K212692 Mariner Pedicle Screw System NKB Class II Orthopedic
2021-09-10 K212540 Explorer TO System MAX Class II Orthopedic
2021-09-01 K212139 Admiral ACP System KWQ Class II Orthopedic
2021-08-30 K211903 Shoreline Threaded TruProfile® Plate KWQ Class II Orthopedic
2021-07-07 K210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System MAX Class II Orthopedic
2021-06-23 K211606 Mariner Deformity System NKB Class II Orthopedic
2021-06-02 K210583 SeaSpine WaveForm™ A Interbody System MAX Class II Orthopedic
2020-12-15 K201755 WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System MAX Class II Orthopedic
2020-11-25 K201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System MAX Class II Orthopedic
2020-09-18 K201073 Seaspine WaveForm C Interbody System OVE Class II Orthopedic
2020-09-14 K201646 Shoreline ACS (Anterior Cervical System) OVE Class II Orthopedic
2020-08-26 K202064 Admiral ACP System KWQ Class II Orthopedic
2020-08-05 K201240 Mariner Cap System OWI Class II Orthopedic
2020-06-10 K200879 SeaSpine Meridian System, SeaSpine Regatta Lateral System MAX Class II Orthopedic
2020-05-28 K200885 Meridian Anterior Plate System, Regatta Lateral Plate System KWQ Class II Orthopedic
2020-05-11 K200290 Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) MQV Class II Orthopedic
2020-04-24 K193636 SeaSpine Reef TH System MAX Class II Orthopedic
2020-03-25 K193615 NorthStar™ OCT Spinal System NKG Class II Orthopedic
2020-03-13 K193418 SeaSpine Skipjack System MAX Class II Orthopedic
2020-02-28 K200381 Daytona® Small Stature Spinal System NKB Class II Orthopedic
2020-02-13 K193224 Daytona® Small Stature Growth Rod Conversion Set PGM Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence