ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY

ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY is an FDA 510(k)-cleared medical device (K910940) 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 9, 1991. Regulation: 8.