All-Suture Dual Anchor System

All-Suture Dual Anchor System is an FDA 510(k)-cleared medical device (K250095) manufactured by Suturetech, 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 September 4, 2025. Regulation: 8.