BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS

BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS is an FDA 510(k)-cleared medical device (K073102) manufactured by Biomet Manufacturing Corp. 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 26, 2007. Regulation: 8.