MODIFICATION TO TSRH SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

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 IDK030285
510k NumberK030285
Device Name:MODIFICATION TO TSRH SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
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 CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-28
Decision Date2003-02-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994321633 K030285 000
00721902704567 K030285 000
00721902714337 K030285 000
00721902727092 K030285 000
00721902727108 K030285 000
00721902727115 K030285 000
00721902727122 K030285 000
00721902727139 K030285 000
00613994321596 K030285 000
00613994321602 K030285 000
00613994321619 K030285 000
00613994321626 K030285 000
00721902701726 K030285 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.