OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)

OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION) is an FDA 510(k)-cleared medical device (K963959) 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 December 18, 1996. Regulation: 8.