MODIFICATION TO TSRH SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

MEDTRONIC SOFAMOR DANEK, INC.

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

Pre-market Notification Details

Device IDK000991
510k NumberK000991
Device Name:MODIFICATION TO TSRH SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle 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 CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-28
Decision Date2000-04-18

NIH GUDID Devices

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