GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD

GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD is an FDA 510(k)-cleared medical device (K984541) manufactured by DePuy Orthopaedics, 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 January 13, 1999. Regulation: 8.