T2 XVBR SPINAL SYSTEM

Spinal Vertebral Body Replacement Device

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for T2 Xvbr Spinal System.

Pre-market Notification Details

• Device ID: K071033
• 510k Number: K071033
• Device Name: T2 XVBR SPINAL SYSTEM
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Christine Scifert
• Correspondent: Christine Scifert; MEDTRONIC SOFAMOR DANEK 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: 2007-04-12
• Decision Date: 2007-08-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994309266	K071033	000
00613994240347	K071033	000
00613994240330	K071033	000
00613994240323	K071033	000
00613994240316	K071033	000
00613994240309	K071033	000
00613994240293	K071033	000
00613994240286	K071033	000
00613994240279	K071033	000
00613994240262	K071033	000
00613994240255	K071033	000
00613994240231	K071033	000
00613994240156	K071033	000
00613994240149	K071033	000
00613994240132	K071033	000
00613994240125	K071033	000
00613994240118	K071033	000
00613994240354	K071033	000
00613994247117	K071033	000
00613994265579	K071033	000
00613994265562	K071033	000
00613994265555	K071033	000
00613994265548	K071033	000
00613994265531	K071033	000
00613994247223	K071033	000
00613994247216	K071033	000
00613994247209	K071033	000
00613994247193	K071033	000
00613994247186	K071033	000
00613994247179	K071033	000
00613994247162	K071033	000
00613994247155	K071033	000
00613994247148	K071033	000
00613994247131	K071033	000
00613994247124	K071033	000
00613994240101	K071033	000