510(k) K131888

T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE by Medtronic Sofamor Danek, Inc. — Product Code MQP

K131888 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek, Inc. for the device "T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE". The FDA issued a decision of Substantially Equivalent on September 23, 2013. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Medtronic Sofamor Danek, Inc. has at least 10 other 510(k) clearances on record.