BowTie™ SI Joint Fusion System

BowTie™ SI Joint Fusion System is an FDA 510(k)-cleared medical device (K232149) manufactured by Sail Fusion, 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 April 19, 2024. Regulation: 8.