TiLink-L SI Joint Fusion System

TiLink-L SI Joint Fusion System is an FDA 510(k)-cleared medical device (K230446) manufactured by SurGenTec, 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 June 6, 2023. Regulation: 8.