VERTE-STACK 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 Verte-stack Spinal System.

Pre-market Notification Details

Device IDK031780
510k NumberK031780
Device Name:VERTE-STACK SPINAL SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard Treharne
CorrespondentRichard Treharne
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-10
Decision Date2003-07-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00721902703966 K031780 000
00721902703492 K031780 000
00721902703485 K031780 000
00885074308647 K031780 000
00885074204420 K031780 000
00885074204413 K031780 000
00885074204406 K031780 000
00885074204390 K031780 000
00885074204376 K031780 000
00885074204369 K031780 000
00885074204352 K031780 000
00721902703515 K031780 000
00721902703843 K031780 000
00721902703850 K031780 000
00721902703959 K031780 000
00721902703942 K031780 000
00721902703935 K031780 000
00721902703928 K031780 000
00721902703911 K031780 000
00721902703904 K031780 000
00721902703898 K031780 000
00721902703881 K031780 000
00721902703874 K031780 000
00721902703867 K031780 000
00885074204307 K031780 000

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