iFuse Implant System® - iFuse-3D implant

iFuse Implant System® - iFuse-3D implant is an FDA 510(k)-cleared medical device (K162733) 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 9, 2017. Regulation: 8.