PRODENSE BONE GRAFT SUBSTITUTE

PRODENSE BONE GRAFT SUBSTITUTE is an FDA 510(k)-cleared medical device (K132656) 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 23, 2014. Regulation: 8.