EPIC Extremity Snap-Off Screw

EPIC Extremity Snap-Off Screw is an FDA 510(k)-cleared medical device (K163038) 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 February 27, 2017. Regulation: 8.