PRODENSE Bone Graft Substitute

PRODENSE Bone Graft Substitute is an FDA 510(k)-cleared medical device (K182823) 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 November 1, 2018. Regulation: 8.