PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT

PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT is an FDA 510(k)-cleared medical device (K970194) manufactured by Stelkast Company. 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 13, 1997. Regulation: 8.