510(k) K141824

MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP by Medtronic Sofamor Danek, Inc. — Product Code MQV

K141824 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek, Inc. for the device "MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP". The FDA issued a decision of Substantially Equivalent on September 5, 2014. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Medtronic Sofamor Danek, Inc. has at least 10 other 510(k) clearances on record.