Acumed Ankle Plating System

Acumed Ankle Plating System is an FDA 510(k)-cleared medical device (K143385) manufactured by Acumed, 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 April 5, 2015. Regulation: 8.