GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE

GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE is an FDA 510(k)-cleared medical device (K914000) manufactured by Depuy, 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 December 3, 1991. Regulation: 8.