TSRH SPINAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

MEDTRONIC SOFAMOR DANEK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Tsrh Spinal System.

Pre-market Notification Details

Device IDK021170
510k NumberK021170
Device Name:TSRH SPINAL SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard W Treharne
CorrespondentRichard W Treharne
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeKWP  
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-12
Decision Date2002-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00721902733468 K021170 000
00721902733451 K021170 000
00721902733437 K021170 000
00721902733420 K021170 000
00721902733406 K021170 000
00721902733390 K021170 000

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