PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT

PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT is an FDA 510(k)-cleared medical device (K970490) 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 May 1, 1997. Regulation: 8.