DEPUY POROUS COATED GLOBAL SHOULDER

DEPUY POROUS COATED GLOBAL SHOULDER is an FDA 510(k)-cleared medical device (K943300) 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 October 30, 1994. Regulation: 8.