SI-Restore Sacroiliac Joint Fixation System

SI-Restore Sacroiliac Joint Fixation System is an FDA 510(k)-cleared medical device (K200868) manufactured by Biofusion Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 16, 2020. Regulation: 8.