PRO-DENSE LoVisc Bone Graft Substitute

PRO-DENSE LoVisc Bone Graft Substitute is an FDA 510(k)-cleared medical device (K200507) 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 October 20, 2020. Regulation: 8.