Arthrex Humeral Plating System and Cerclage Button

Arthrex Humeral Plating System and Cerclage Button is an FDA 510(k)-cleared medical device (K243995) manufactured by Arthrex, 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 March 25, 2025. Regulation: 8.