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 Tsrh Spinal System.

Pre-market Notification Details

Device IDK031967
510k NumberK031967
Device Name:TSRH SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard Treharne
CorrespondentRichard Treharne
MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
Subsequent Product CodeNKB
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-26
Decision Date2003-09-17
Summary:summary

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