510(k) K040405

CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

K040405 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials, Inc. for the device "CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY". The FDA issued a decision of Substantially Equivalent on March 5, 2004. 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.