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Intervertebral Fusion Device With Integrated Fixation, Lumbar
FDA product code OVD · Class 2 · Orthopedic
42,567
Registered devices
1,268
Adverse events
36
Recalls
204
510(k) clearances
Devices with this code
Brickyard Stand-Alone ALIF — Altus Spine, LLCTiBrid™-SA — OMNIA MEDICAL, LLCTiBrid™-SA — OMNIA MEDICAL, LLCIdentiTi — ALPHATEC SPINE, INC.CoRoent — Nuvasive, Inc.Brigade — Nuvasive, Inc.Brigade — Nuvasive, Inc.Brigade — Nuvasive, Inc.NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE, LLCNEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE, LLCIdentiTi — ALPHATEC SPINE, INC.Timberline MPF Lateral Modular Plate Fixation System — Highridge Medical, LLCDyna-Link Stand-Alone Anterior Lumbar System — Life Spine, Inc.SCARLET® AL-T — SpineArt SAENDOSKELETON® TL Hyperlordotic Sterile Barrier System — TITAN SPINE, LLCENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology — TITAN SPINE, LLCZAVATION — Zavation LLCSolar™ Interbody Fusion System — DEGEN MEDICAL, INC.SAHARA™ Stabilization System — VB Spine LLCROI-A — LDR Spine Usa, Inc.ROI-A — LDR Spine Usa, Inc.TrellOss®-A SA — NEXXT SPINE, LLCSIRION — Astura MedicalEL CAPITAN — Astura Medical
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-23 | Novapproach Spine, LLC | Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant |
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2025-02-28 | Stryker Spine | Potential for the gold unlock button to separate from the inserter. |
| 2025-02-28 | Stryker Spine | Potential for the gold unlock button to separate from the inserter. |
| 2025-02-28 | Stryker Spine | Potential for the gold unlock button to separate from the inserter. |
| 2025-02-28 | Stryker Spine | Potential for the gold unlock button to separate from the inserter. |
| 2025-01-03 | XTANT Medical Holdings, Inc | Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date. |
| 2024-07-15 | Omnia Medical | Failure of fusion system instruments in the field. |
| 2024-07-15 | Omnia Medical | Failure of fusion system instruments in the field. |
| 2024-01-26 | Alphatec Spine, Inc. | Due to reports of intraoperative graft bolt implantation breakages. |
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