ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE

ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE is an FDA 510(k)-cleared medical device (K081979) manufactured by Apatech , Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 5, 2008. Regulation: 8.