SI-BONE iFuse Implant System®

SI-BONE iFuse Implant System® is an FDA 510(k)-cleared medical device (K193524) manufactured by SI-BONE, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 30, 2020. Regulation: 8.