510(k) K160566

Cerasorb Ortho Foam by Curasan AG — Product Code MQV

K160566 is an FDA 510(k) premarket notification submitted by Curasan AG for the device "Cerasorb Ortho Foam". The FDA issued a decision of Substantially Equivalent on December 2, 2016. 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.