OGmend® Implant Enhancement System

OGmend® Implant Enhancement System is an FDA 510(k)-cleared medical device (K233223) manufactured by Woven Orthopedic Technologies. 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 25, 2023. Regulation: 8.