510(k) K181721

Ceracell Ortho Foam by Curasan AG — Product Code MQV

K181721 is an FDA 510(k) premarket notification submitted by Curasan AG for the device "Ceracell Ortho Foam". The FDA issued a decision of Substantially Equivalent on September 17, 2018. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Curasan AG has at least 9 other 510(k) clearances on record.