FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS

FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS is an FDA 510(k)-cleared medical device (K920698) manufactured by Orthomet, 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 August 2, 1992. Regulation: 8.