510(k) K061880

ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC by Isotis NV — Product Code MQV

K061880 is an FDA 510(k) premarket notification submitted by Isotis NV for the device "ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC". The FDA issued a decision of Substantially Equivalent on August 15, 2007. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Isotis NV has at least 7 other 510(k) clearances on record.