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 Carlsmed, Inc., Nu Vasive, Incorporated and Nexus Spine, LLC.