510(k) K183510

T2 STRATOSPHERE Expandable Corpectomy System by Medtronic Sofamor Danek USA, Inc. — Product Code MQP

K183510 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek USA, Inc. for the device "T2 STRATOSPHERE Expandable Corpectomy System". The FDA issued a decision of Substantially Equivalent on January 16, 2019. 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 USA, Inc. has at least 10 other 510(k) clearances on record.