510(k) K070751

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY by Isotis Orthobiologics, Inc. — Product Code MQV

K070751 is an FDA 510(k) premarket notification submitted by Isotis Orthobiologics, Inc. for the device "ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY". The FDA issued a decision of Substantially Equivalent on October 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 Orthobiologics, Inc. has at least 9 other 510(k) clearances on record.