OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft

OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft is an FDA 510(k)-cleared medical device (K200064) manufactured by SurGenTec, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 2020. Regulation: 8.