Skeletal Dynamics Midshaft Humerus Plating System

Skeletal Dynamics Midshaft Humerus Plating System is an FDA 510(k)-cleared medical device (K200701) 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 May 13, 2020. Regulation: 8.