Dunamis Screw and Suture Locking System

Dunamis Screw and Suture Locking System is an FDA 510(k)-cleared medical device (K250867) manufactured by Dunamis Medical, 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 August 14, 2025. Regulation: 8.