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Intervertebral Fusion Device With Bone Graft, Cervical
FDA product code ODP · Class 2 · Orthopedic
55,733
Registered devices
1,118
Adverse events
11
Recalls
354
510(k) clearances
Devices with this code
IVA Cage Ti — DIOMEDICAL CO.,LTD.Cross-Fuse® PEEK IBF System — Pioneer Surgical Technology, Inc.LnK Cervical Interbody Fusion Cage System — L&K BIOMED CO. ,LTD.E3D®-C Interbody System — Evolution Spine LLCCoRoent — Nuvasive, Inc.Endoskeleton TCS — TITAN SPINE, LLCTyber Medical — Tyber Medical, LLCTyber Medical — Tyber Medical, LLCPlateau A — Life Spine, Inc.Latitude-C AM™ Cervical Interbody Fusion System — DEGEN MEDICAL, INC.Latitude-C AM™ Cervical Interbody Fusion System — DEGEN MEDICAL, INC.Latitude-C AM™ Cervical Interbody Fusion System — DEGEN MEDICAL, INC.ZAVATION — Zavation LLCE3D®-C Interbody System — Evolution Spine LLCTIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM — BIOMET SPINE LLCCoRoent — Nuvasive, Inc.CoRoent — Nuvasive, Inc.CoRoent — Nuvasive, Inc.Valeo Spacer System — SINTX Technologies, Inc.Valeo Spacer System — SINTX Technologies, Inc.Tyber Medical — Tyber Medical, LLCApache — Genesys Orthopedics Systems LLCIdentiTi — ALPHATEC SPINE, INC.Plateau C — Life Spine, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2020-09-30 | XTANT Medical | Cervical Implants contain a label that incorrectly identifies the grade of titanium used. |
| 2013-10-07 | RTI 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 |
| 2013-02-05 | SpineNet | The 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 |
| 2012-06-15 | Exactech, Inc. | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws |
| 2011-09-23 | Synthes 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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