Humeris® 135 Shoulder System

Humeris® 135 Shoulder System is an FDA 510(k)-cleared medical device (K222936) manufactured by Fx Shoulder USA, 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 6, 2022. Regulation: 8.