FEMORAL INTRAFIX SCREW AND SHEATH

FEMORAL INTRAFIX SCREW AND SHEATH is an FDA 510(k)-cleared medical device (K063577) manufactured by Johnson & Johnson 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 January 24, 2007. Regulation: 8.