SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty

SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty is an FDA 510(k)-cleared medical device (K233490) manufactured by Bioventus, 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 December 4, 2023. Regulation: 8.