Treace Medical Concepts (TMC) Plating System

Treace Medical Concepts (TMC) Plating System is an FDA 510(k)-cleared medical device (K153531) manufactured by Treace Medical Concepts, 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 January 6, 2016. Regulation: 8.