F3D Cervical Stand-Alone Interbody Fusion System

F3D Cervical Stand-Alone Interbody Fusion System is an FDA 510(k)-cleared medical device (K200087) 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 June 14, 2020. Regulation: 8.