Skeletal Dynamics Ulnar Shortening Plating System

Skeletal Dynamics Ulnar Shortening Plating System is an FDA 510(k)-cleared medical device (K201962) manufactured by Skeletal Dynamics, 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 October 12, 2020. Regulation: 8.