ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT

ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT is an FDA 510(k)-cleared medical device (K921182) 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 July 22, 1993. Regulation: 8.