SIGNAFUSE Bioactive Bone Graft

SIGNAFUSE Bioactive Bone Graft is an FDA 510(k)-cleared medical device (K193513) manufactured by Bioventus. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 17, 2020. Regulation: 8.