510(k) K122513

CLEARED UNDER GRAFTON II EDBM by Medtronic Sofamor Danek, Inc. — Product Code MBP

K122513 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek, Inc. for the device "CLEARED UNDER GRAFTON II EDBM". The FDA issued a decision of Substantially Equivalent on March 6, 2013. The device falls under product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)), a Class II device regulated under 21 CFR 888.3045. Medtronic Sofamor Danek, Inc. has at least 10 other 510(k) clearances on record.