510(k) K040216

CERASORB M ORTHO by Curasan AG — Product Code MQV

K040216 is an FDA 510(k) premarket notification submitted by Curasan AG for the device "CERASORB M ORTHO". The FDA issued a decision of Substantially Equivalent on March 26, 2004. 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.