Blue Topaz Sacroiliac Screw System

Blue Topaz Sacroiliac Screw System is an FDA 510(k)-cleared medical device (K213590) manufactured by Osseus Fusion Systems, 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 February 28, 2022. Regulation: 8.