METAGEN ALL POLY ACETABULAR CUP SYSTEM

METAGEN ALL POLY ACETABULAR CUP SYSTEM is an FDA 510(k)-cleared medical device (K964003) manufactured by Metagen, LLC. 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 20, 1997. Regulation: 8.