Epic Extremity Cannulated Screw System

Epic Extremity Cannulated Screw System is an FDA 510(k)-cleared medical device (K153333) manufactured by Epic Extremity, 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 18, 2016. Regulation: 8.