AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY

AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY is an FDA 510(k)-cleared medical device (K930595) 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 21, 1993. Regulation: 8.