CUSTOM FLANGED ACETABULAR COMPONENT

CUSTOM FLANGED ACETABULAR COMPONENT is an FDA 510(k)-cleared medical device (K983035) 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 November 22, 1998. Regulation: 8.