Glenoid Baseplate with Screw

Glenoid Baseplate with Screw is an FDA 510(k)-cleared medical device (K192799) 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 February 20, 2020. Regulation: 8.