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 4Web Medical, Inc., SeaSpine Orthopedics Corporation and GS Medical Co., Ltd..