DISTAL ELBOW PLATING SYSTEM

DISTAL ELBOW PLATING SYSTEM is an FDA 510(k)-cleared medical device (K140892) manufactured by Skeletal Dynamics, 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 27, 2014. Regulation: 8.