510(k) K091321

OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY by Bacterin International, Inc. — Product Code MQV

K091321 is an FDA 510(k) premarket notification submitted by Bacterin International, Inc. for the device "OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY". The FDA issued a decision of Substantially Equivalent on September 11, 2009. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Bacterin International, Inc. has at least 3 other 510(k) clearances on record.