SambaScrew 3D SI Fusion System

SambaScrew 3D SI Fusion System is an FDA 510(k)-cleared medical device (K183342) manufactured by Orthofix, 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 April 29, 2019. Regulation: 8.