510(k) K082615

GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES by Osteotech, Inc. — Product Code MQV

K082615 is an FDA 510(k) premarket notification submitted by Osteotech, Inc. for the device "GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES". The FDA issued a decision of Substantially Equivalent on October 16, 2008. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Osteotech, Inc. has at least 10 other 510(k) clearances on record.