AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY

AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY is an FDA 510(k)-cleared medical device (K924698) 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 26, 1993. Regulation: 8.