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, GS Medical Co., Ltd. and Elevation Spine.
FDA 510(k) Cleared Intervertebral Fusion Device With Integrated Fixation, Cervical Devices (Product Code OVE)
About Product Code OVE - Regulatory Context
510(k) Submission Activity
160 total 510(k) submissions under product code OVE since 2007, with 160 receiving FDA clearance (average review time: 135 days).
Submission volume has declined in recent years - 17 submissions in the last 24 months compared to 27 in the prior period.
FDA Review Time
Recent submissions under OVE have taken an average of 108 days to reach a decision - down from 138 days historically, suggesting improved FDA processing for this classification.
OVE devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →