Corelink Foundation 3D Anterior Lumbar System

Corelink Foundation 3D Anterior Lumbar System is an FDA 510(k)-cleared medical device (K180556) manufactured by Corelink, 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 July 26, 2018. Regulation: 8.