OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS

OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS is an FDA 510(k)-cleared medical device (K974685) 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 September 21, 1998. Regulation: 8.