TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY

TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY is an FDA 510(k)-cleared medical device (K911198) 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 May 22, 1991. Regulation: 8.