MODIFIED 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 Modified Verte-stack Spinal System.

Pre-market Notification Details

Device IDK030735
510k NumberK030735
Device Name:MODIFIED 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 Received2003-03-10
Decision Date2003-04-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00721902984532 K030735 000
00721902984471 K030735 000
00721902984464 K030735 000
00721902984457 K030735 000
00721902984440 K030735 000
00721902984341 K030735 000
00721902984334 K030735 000
00721902984198 K030735 000

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