OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM

OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM is an FDA 510(k)-cleared medical device (K942900) 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 14, 1995. Regulation: 8.