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 IDK131888
510k NumberK131888
Device Name:T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
ClassificationSpinal Vertebral Body Replacement Device
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactBecky Ronner
CorrespondentBecky Ronner
MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-25
Decision Date2013-09-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000027605 K131888 000
00613994452016 K131888 000
00613994452023 K131888 000
00613994452030 K131888 000
00613994452047 K131888 000
00613994452054 K131888 000
00613994452061 K131888 000
00613994452078 K131888 000
00613994452085 K131888 000
00613994452092 K131888 000
00613994452108 K131888 000
00613994452009 K131888 000
00613994451996 K131888 000
00613994238986 K131888 000
00613994238993 K131888 000
00613994239006 K131888 000
00613994239013 K131888 000
00613994239020 K131888 000
00613994239037 K131888 000
00613994239044 K131888 000
00613994239051 K131888 000
00613994451972 K131888 000
00613994451989 K131888 000
00613994452115 K131888 000
00613994452122 K131888 000
00613994452139 K131888 000
00613994676290 K131888 000
00613994676306 K131888 000
00613994676313 K131888 000
00613994676320 K131888 000
00613994676337 K131888 000
00613994676344 K131888 000
00613994676351 K131888 000
00613994676368 K131888 000
00613994676375 K131888 000
00613994676382 K131888 000
00613994676283 K131888 000
00613994676276 K131888 000
00613994452146 K131888 000
00613994452153 K131888 000
00613994452160 K131888 000
00613994676153 K131888 000
00613994676160 K131888 000
00613994676177 K131888 000
00613994676184 K131888 000
00613994676191 K131888 000
00613994676207 K131888 000
00613994676214 K131888 000
00613994676399 K131888 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.