AMK FIXED STEM CEMENTED TIBIAL TRAY

AMK FIXED STEM CEMENTED TIBIAL TRAY is an FDA 510(k)-cleared medical device (K922620) manufactured by Depuy, 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 September 2, 1992. Regulation: 8.