510(k) K030131

OSSATURA BCP BONE VOID FILLER by Isotis NV — Product Code MQV

K030131 is an FDA 510(k) premarket notification submitted by Isotis NV for the device "OSSATURA BCP BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on May 20, 2003. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Isotis NV has at least 7 other 510(k) clearances on record.