Citregen Tendon Interference Screw and Citrelock

Citregen Tendon Interference Screw and Citrelock is an FDA 510(k)-cleared medical device (K200725) manufactured by Acuitive Technologies. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 6, 2020. Regulation: 8.