ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND

ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND is an FDA 510(k)-cleared medical device (K965002) manufactured by Encore Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 26, 1997. Regulation: 8.