510(k) K170917

Bi-Ostetic Bioactive Glass Foam by Berkeley Advanced Biomaterials — Product Code MQV

K170917 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials for the device "Bi-Ostetic Bioactive Glass Foam". The FDA issued a decision of Substantially Equivalent on October 30, 2017. 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 has at least 10 other 510(k) clearances on record.