TSRH SPINAL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

MEDTRONIC SOFAMOR DANEK, INC.

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

Pre-market Notification Details

Device IDK010720
510k NumberK010720
Device Name:TSRH SPINAL SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard W Treharne
CorrespondentRichard W Treharne
MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-12
Decision Date2001-04-11

NIH GUDID Devices

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