ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT

ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT is an FDA 510(k)-cleared medical device (K936079) 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 September 6, 1994. Regulation: 8.