ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE

ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE is an FDA 510(k)-cleared medical device (K071206) 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 May 30, 2007. Regulation: 8.