VantageTM Lumbar Decompression Kit

VantageTM Lumbar Decompression Kit is an FDA 510(k)-cleared medical device (K252546) manufactured by Allevion Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 11, 2026. Regulation: 8.