ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS

ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS is an FDA 510(k)-cleared medical device (K053587) manufactured by Ortho Development 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 16, 2006. Regulation: 8.