EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS

EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS is an FDA 510(k)-cleared medical device (K933610) manufactured by Exactech, 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 January 16, 1995. Regulation: 8.