REGENEREX POROUS TITANIUM SLEEVE AUGMENTS

REGENEREX POROUS TITANIUM SLEEVE AUGMENTS is an FDA 510(k)-cleared medical device (K072336) manufactured by Biomet Manufacturing 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 November 4, 2007. Regulation: 8.