OSSATURA BCP BONE VOID FILLER

OSSATURA BCP BONE VOID FILLER is an FDA 510(k)-cleared medical device (K030131) manufactured by Isotis NV. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 19, 2003. Regulation: 8.