AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER

AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER is an FDA 510(k)-cleared medical device (K926334) 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 October 17, 1994. Regulation: 8.