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..
FDA 510(k) Cleared Intervertebral Fusion Device With Bone Graft, Lumbar Devices (Product Code MAX)
About Product Code MAX - Regulatory Context
510(k) Submission Activity
886 total 510(k) submissions under product code MAX since 2007, with 886 receiving FDA clearance (average review time: 130 days).
Submission volume has remained relatively stable over the observed period, with 64 submissions in the last 24 months.
FDA Review Time
FDA review times for MAX submissions have been consistent, averaging 115 days recently vs 131 days historically.
MAX devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →