510(k) K041889

TRI-OSTETIC by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

K041889 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials, Inc. for the device "TRI-OSTETIC". The FDA issued a decision of Substantially Equivalent on August 19, 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.