AMK MODULAR TIBIAL WEDGE SYSTEM

AMK MODULAR TIBIAL WEDGE SYSTEM is an FDA 510(k)-cleared medical device (K904205) 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 October 21, 1990. Regulation: 8.