OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS

OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS is an FDA 510(k)-cleared medical device (K930187) 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 2, 1994. Regulation: 8.