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, Carlsmed, Inc. and Nexus Spine, LLC.
FDA 510(k) Cleared Intervertebral Fusion Device With Integrated Fixation, Lumbar Devices (Product Code OVD)
About Product Code OVD - Regulatory Context
510(k) Submission Activity
198 total 510(k) submissions under product code OVD since 2007, with 198 receiving FDA clearance (average review time: 130 days).
Submission volume has remained relatively stable over the observed period, with 19 submissions in the last 24 months.
FDA Review Time
Recent submissions under OVD have taken an average of 103 days to reach a decision - down from 133 days historically, suggesting improved FDA processing for this classification.
OVD devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →