ARC SURGICAL BONE REDUCTION SCREW

ARC SURGICAL BONE REDUCTION SCREW is an FDA 510(k)-cleared medical device (K063244) manufactured by Arc Surgical, 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 December 26, 2006. Regulation: 8.