OSTEONICS(R) THREADED HA ACETABULAR SHELLS

OSTEONICS(R) THREADED HA ACETABULAR SHELLS is an FDA 510(k)-cleared medical device (K945691) 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 March 16, 1995. Regulation: 8.