510(k) K201535

Cerament Bone Void Filler by Bonesupport AB — Product Code MQV

K201535 is an FDA 510(k) premarket notification submitted by Bonesupport AB for the device "Cerament Bone Void Filler". The FDA issued a decision of Substantially Equivalent on October 16, 2020. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Bonesupport AB has at least 6 other 510(k) clearances on record.