510(k) K051695

MARROW PLUS (M+) by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

K051695 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials, Inc. for the device "MARROW PLUS (M+)". The FDA issued a decision of Substantially Equivalent on July 19, 2005. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Berkeley Advanced Biomaterials, Inc. has at least 10 other 510(k) clearances on record.