510(k) K053213

BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

K053213 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials, Inc. for the device "BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM". The FDA issued a decision of Substantially Equivalent on July 6, 2006. 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.