FDA Product Code MAX: Intervertebral Fusion Device With Bone Graft, Lumbar
FDA product code MAX covers lumbar intervertebral fusion devices with bone graft.
These spinal implants are designed to stabilize a vertebral segment and promote bone fusion across the disc space. They are used in both minimally invasive and open lumbar fusion procedures.
MAX devices are Class II medical devices, regulated under 21 CFR 888.3080 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Life Spine, Inc., SeaSpine Orthopedics Corporation and Alphatec Spine, Inc..
List of Intervertebral Fusion Device With Bone Graft, Lumbar devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Intervertebral Fusion Device With Bone Graft, Lumbar devices (product code MAX). 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 →