TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER

TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER is an FDA 510(k)-cleared medical device (K946313) manufactured by Smith and Nephew Donjoy, 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 March 16, 1995. Regulation: 8.