510(k) K050666

GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

K050666 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials, Inc. for the device "GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES". The FDA issued a decision of Substantially Equivalent on April 11, 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.