SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES

SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES is an FDA 510(k)-cleared medical device (K080522) 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 May 22, 2008. Regulation: 8.