SeaSpine Orthopedics Corporation
SeaSpine Orthopedics Corporation holds FDA 510(k) medical device clearances, first cleared 2016, most recent 2026, with 10 FDA device recalls on record.
Top product codes for SeaSpine Orthopedics Corporation
FDA recalls by SeaSpine Orthopedics Corporation
- Z-2762-2026 — SeaSpine Polyaxial Head REF Number: 41-3010
- Z-0937-2026 — Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-400145; Navigation, 5.5mm Drill, REF: PC2-400155; Navigation, 3.5mm Tap, REF: PC2-400235; Navigation, 4.0mm Tap, REF: PC2-400240; Navigation, 4.5mm Tap, REF: PC2-400245; Navigation, 4.5mm Dual Lead Tap, REF: PC2-400345; Navigation, 5.5mm Dual Lead Tap, REF: PC2-400355
- Z-2554-2025 — Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
- Z-0751-2025 — Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
- Z-0752-2025 — Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No
- Z-2357-2024 — Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
- Z-2235-2024 — Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
- Z-2234-2024 — Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
- Z-1620-2024 — Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
- Z-1605-2024 — Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of Mariner RDX Alpha Instruments and Implants, REF: AMRDX and Mariner RDX TD Alpha Implants, REF: AMRDXTD, which are pedicle screw systems.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by SeaSpine Orthopedics Corporation
- K253420 — Admiral ACP System +18 more
- K250908 — Virata Spinal Fixation System
- K243659 — FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
- K242273 — Cove Putty, OsteoCove Putty
- K241466 — Shoreline ACS Interbody System +10 more
- K240566 — Reef L Interbody System; WaveForm L Interbody System
- K232566 — NewPort Spinal System +6 more
- K233694 — Meridian Interbody System; WaveForm A Interbody System
- K233414 — Shoreline ACS Interbody System; Shoreline RT Interbody System
- K232668 — Cove Strip, OsteoCove Strip
- K231030 — Cove Putty, OsteoCove Putty
- K230486 — Cove Strip
- K220296 — Manta Ray TDF Spacer
- K222753 — SeaSpine 7D Navigation Instruments
- K222732 — WaveForm A Interbody System
- K222110 — Mariner RDX System
- K220711 — SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
- K213420 — WaveForm L System, WaveForm TO System, WaveForm TA System
- K212904 — SeaSpine WaveForm C Interbody System
- K213359 — SeaSpine WaveForm, C Interbody System
- K212692 — Mariner Pedicle Screw System
- K212540 — Explorer TO System
- K212139 — Admiral ACP System
- K211903 — Shoreline Threaded TruProfile® Plate
- K210497 — SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene, SeaSpine Vu ePOD System, SeaSpine Vu aPOD 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
- K211606 — Mariner Deformity System
- K210583 — SeaSpine WaveForm A Interbody System
- K201755 — WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System
- K201193 — SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene +6 more
- K201073 — Seaspine WaveForm C Interbody System
- K201646 — Shoreline ACS (Anterior Cervical System)
- K202064 — Admiral ACP System
- K201240 — Mariner Cap System
- K200879 — SeaSpine Meridian System, SeaSpine Regatta Lateral System
- K200885 — Meridian Anterior Plate System, Regatta Lateral Plate System
- K200290 — Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)
- K193636 — SeaSpine Reef TH System
- K193615 — NorthStar OCT Spinal System
- K193418 — SeaSpine Skipjack System
- K200381 — Daytona® Small Stature Spinal System
- K193224 — Daytona® Small Stature Growth Rod Conversion Set
- K192132 — SeaSpine Beachside System
- K193040 — Resorbable Mesh Device
- K191648 — Mariner MIS Pedicle Screw System; SeaSpine Navigation System
- K183639 — Mariner Outrigger Revision System
- K190655 — SeaSpine® Shoreline ACS- Anterior Cervical Standalone System
- K183083 — Shoreline Cervical Interbody RT System
- K181079 — SeaSpine Regatta Lateral System
- K180686 — SeaSpine Daytona Small Stature Spinal System
- K172517 — SeaSpine Navigation System
- K173606 — SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device
- K173334 — SeaSpine Spinous Process System
- K180176 — SeaSpine NewPort Spinal System
- K173882 — SeaSpine Mariner Pedicle Screw System
- K173521 — SeaSpine Cabo ACP (Anterior Cervical Plate) System
- K172926 — SeaSpine Vu cPOD, Zuma-C, Complete Cervical
- K173260 — SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica +2 more
- K172130 — Resorbable Mesh Device
- K173022 — SeaSpine Ventura NanoMetalene System
- K171046 — SeaSpine Cambria System
- K170569 — SeaSpine Shoreline ACS - Anterior Cervical Standalone System
- K163604 — SeaSpine® Daytona® Small Stature Spinal System
- K162351 — SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device
- K162715 — SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene +1 more
- K161081 — SeaSpine Shoreline ACS - Anterior Cervical Standalone System
- K161535 — SeaSpine® NewPort Spinal System
- K160902 — Mariner Pedicle Screw System
Data sourced from openFDA. This site is unofficial and independent of the FDA.