PRECISION OSTEOFLEX FEMORAL COMPONENT

PRECISION OSTEOFLEX FEMORAL COMPONENT is an FDA 510(k)-cleared medical device (K903630) 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 22, 1994. Regulation: 8.