FDA Product Code OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical
FDA product code OVE covers cervical intervertebral fusion devices with integrated fixation.
These single-piece implants combine an interbody spacer with integrated anterior fixation screws or blades, providing both disc space support and vertebral stabilization without a separate plate. They are used in one- or two-level anterior cervical discectomy and fusion procedures.
OVE devices are Class II medical devices, regulated under 21 CFR 888.3080 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include SeaSpine Orthopedics Corporation, Genesys Spine and Signus Medizintechnik GmbH.
List of Intervertebral Fusion Device With Integrated Fixation, Cervical devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Intervertebral Fusion Device With Integrated Fixation, Cervical devices (product code OVE). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →