32mm Glenosphere and Humeral Cup

32mm Glenosphere and Humeral Cup is an FDA 510(k)-cleared medical device (K192206) 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 October 7, 2019. Regulation: 8.