PRO-DENSE BONE GRAFT SUBSTITUTE

PRO-DENSE BONE GRAFT SUBSTITUTE is an FDA 510(k)-cleared medical device (K113871) manufactured by Wrightmedicaltechnologyinc. 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 24, 2013. Regulation: 8.