510(k) K071004

OSTEOCRETE BONE VOID FILLER by Bone Solutions, Inc. — Product Code MQV

K071004 is an FDA 510(k) premarket notification submitted by Bone Solutions, Inc. for the device "OSTEOCRETE BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on May 21, 2009. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Bone Solutions, Inc. has at least 7 other 510(k) clearances on record.