F3D-C2 Cervical Stand-Alone System

F3D-C2 Cervical Stand-Alone System is an FDA 510(k)-cleared medical device (K211417) 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 February 3, 2022. Regulation: 8.