SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES

SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES is an FDA 510(k)-cleared medical device (K081353) manufactured by Synthes (Usa). This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 22, 2008. Regulation: 8.