FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS

FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS is an FDA 510(k)-cleared medical device (K955563) 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 August 8, 1996. Regulation: 8.