FDA Product Code OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Under FDA product code OVD, lumbar intervertebral fusion devices with integrated fixation are cleared for combined interbody fusion and segmental stabilization.
These devices integrate both the interbody spacer and fixation elements — typically screws or blades — into a single implant, eliminating the need for separate posterior instrumentation in some patients. They are used in minimally invasive lumbar fusion procedures.
OVD devices are Class II medical devices, regulated under 21 CFR 888.3080 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Nu Vasive, Incorporated, Alphatec Spine, Inc. and Astura Medical.
List of Intervertebral Fusion Device With Integrated Fixation, Lumbar 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, Lumbar devices (product code OVD). 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 →