SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES

SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES is an FDA 510(k)-cleared medical device (K001945) 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 September 21, 2000. Regulation: 8.