BIOSURE REGENESORB interference Screw

BIOSURE REGENESORB interference Screw is an FDA 510(k)-cleared medical device (K142948) manufactured by Smith & Nephew, Inc.. 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 12, 2015. Regulation: 8.