T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE

Spinal Vertebral Body Replacement Device

MEDTRONIC SOFAMOR DANEK, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for T2 Xvbr Spinal System, T2 Altitude Expandable Corpectomy Device.

Pre-market Notification Details

• Device ID: K131888
• 510k Number: K131888
• Device Name: T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Becky Ronner
• Correspondent: Becky Ronner; MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-06-25
• Decision Date: 2013-09-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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