Home › Device types › OVD
Intervertebral Fusion Device With Integrated Fixation, Lumbar
FDA product code OVD · Class 2 · Orthopedic
0
Registered devices
1,271
Adverse events
36
Recalls
205
510(k) clearances
Devices with this code
Meridian — Seaspine Orthopedics CorporationStable-L™ — NEXUS SPINE, L.L.C.OneLIF™ — Novapproach Spine LLCEndoskeleton TAS — TITAN SPINE, LLCIrix-A Lumbar Integrated Fusion System — Xtant Medical Holdings, Inc.Axle Interspinous Fusion System — Xtant Medical Holdings, Inc.Gladstone ALIF Cage — SIGNATURE ORTHOPAEDICS PTY LTDIdentiTi — ALPHATEC SPINE, INC.ENDOSKELETON® TAS nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.Zavation — Zavation LLCMeridian — Seaspine Orthopedics CorporationDIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.OneLIF™ — Novapproach Spine LLCIdentiTi — ALPHATEC SPINE, INC.Transcend — ALPHATEC SPINE, INC.TRANSCEND NANOTEC — ALPHATEC SPINE, INC.IDENTITi NANOTEC — ALPHATEC SPINE, INC.IDENTITi NANOTEC — ALPHATEC SPINE, INC.Dakota ALIF System — PRECISION SPINE, INC.ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology — TITAN SPINE, LLCZavation — Zavation LLCZavation — Zavation LLCENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology — TITAN SPINE, LLCSolar™ Interbody Fusion System — DEGEN MEDICAL, INC.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.