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Intervertebral Fusion Device With Bone Graft, Cervical

FDA product code ODP · Class 2 · Orthopedic

55,494
Registered devices
1,117
Adverse events
11
Recalls
352
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-11-03Orthofix U.S. LLCLabeling contains claims that are not consistently present.
2025-11-03Orthofix U.S. LLCLabeling contains claims that are not consistently present.
2023-07-12Medicrea InternationalThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12Medicrea InternationalThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12Medicrea InternationalThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2020-09-30XTANT MedicalCervical Implants contain a label that incorrectly identifies the grade of titanium used.
2013-10-07RTI Surgical, Inc.As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented
2013-02-05SpineNetThe recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have be
2012-06-15Exactech, Inc.Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws
2011-09-23Synthes USA (HQ), Inc.LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials referenc

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