COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE

COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE is an FDA 510(k)-cleared medical device (K131353) manufactured by Biomet Manufacturing Corp. 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, 2013. Regulation: 8.