CATAMARAN™ SI Joint Fusion System

CATAMARAN™ SI Joint Fusion System is an FDA 510(k)-cleared medical device (K260477) manufactured by Tenon 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 7, 2026. Regulation: 8.