OSTEOLOCK ACETABULAR SHELL SYSTEM

OSTEOLOCK ACETABULAR SHELL SYSTEM is an FDA 510(k)-cleared medical device (K971854) manufactured by Howmedica 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 July 29, 1997. Regulation: 8.