The Rialto™ SI Fusion System

The Rialto™ SI Fusion System is an FDA 510(k)-cleared medical device (K251395) manufactured by Medtronic Sofamor Danek USA, 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 June 25, 2025. Regulation: 8.