OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS

OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS is an FDA 510(k)-cleared medical device (K980774) 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 April 28, 1998. Regulation: 8.