Treace Medical Concepts (TMC) Hammertoe Fixation System

Treace Medical Concepts (TMC) Hammertoe Fixation System is an FDA 510(k)-cleared medical device (K222564) 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 November 14, 2022. Regulation: 8.