CorticaLINK Spinal Fusion Platform

CorticaLINK Spinal Fusion Platform is an FDA 510(k)-cleared medical device (K193465) manufactured by Spine Smith Holdings, 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 January 9, 2020. Regulation: 8.