OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP

OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP is an FDA 510(k)-cleared medical device (K963671) manufactured by Osteonics 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 February 2, 1997. Regulation: 8.