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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

Recent recalls

DateFirmReason
2026-04-23Novapproach Spine, LLCIntervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant
2025-11-03Orthofix U.S. LLCLabeling contains claims that are not consistently present.
2025-02-28Stryker SpinePotential for the gold unlock button to separate from the inserter.
2025-02-28Stryker SpinePotential for the gold unlock button to separate from the inserter.
2025-02-28Stryker SpinePotential for the gold unlock button to separate from the inserter.
2025-02-28Stryker SpinePotential for the gold unlock button to separate from the inserter.
2025-01-03XTANT Medical Holdings, IncCertain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
2024-07-15Omnia MedicalFailure of fusion system instruments in the field.
2024-07-15Omnia MedicalFailure of fusion system instruments in the field.
2024-01-26Alphatec Spine, Inc.Due to reports of intraoperative graft bolt implantation breakages.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.