FOUNDATION KNEE SYSTEM TIBIAL COMPONENT

FOUNDATION KNEE SYSTEM TIBIAL COMPONENT is an FDA 510(k)-cleared medical device (K970031) manufactured by Encore Orthopedics, 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 April 1, 1997. Regulation: 8.