PROFUSION BONE VOID FILLER KIT

PROFUSION BONE VOID FILLER KIT is an FDA 510(k)-cleared medical device (K031838) manufactured by Biogeneration. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 29, 2003. Regulation: 8.