iFuse Implant System- iFuse Navigation

iFuse Implant System- iFuse Navigation is an FDA 510(k)-cleared medical device (K172268) manufactured by SI-BONE, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 2017. Regulation: 8.