BIO-INTRAFIX TIBIAL SCREW AND SHEATH

BIO-INTRAFIX TIBIAL SCREW AND SHEATH is an FDA 510(k)-cleared medical device (K032167) manufactured by Mitek Worldwide. 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 14, 2003. Regulation: 8.