DYNAMIS™ SI Screw System

DYNAMIS™ SI Screw System is an FDA 510(k)-cleared medical device (K243565) manufactured by Promethean Restorative, 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 February 27, 2025. Regulation: 8.