PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE

PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE is an FDA 510(k)-cleared medical device (K933875) 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 February 28, 1994. Regulation: 8.