TRIATHLON LOW PROFILE TIBIAL TRAY

TRIATHLON LOW PROFILE TIBIAL TRAY is an FDA 510(k)-cleared medical device (K062037) manufactured by Howmedica Osteonics Corp.. 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, 2006. Regulation: 8.