BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD

BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD is an FDA 510(k)-cleared medical device (K915596) manufactured by Biomet, 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 March 10, 1992. Regulation: 8.