MODIFICATION TO CD 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 Modification To Cd Spinal System.

Pre-market Notification Details

Device IDK000453
510k NumberK000453
Device Name:MODIFICATION TO CD 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 Received2000-02-11
Decision Date2000-03-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00721902824791 K000453 000
00721902180170 K000453 000
00721902507298 K000453 000
00721902507380 K000453 000
00721902507397 K000453 000
00721902507403 K000453 000
00721902507410 K000453 000
00721902507427 K000453 000
00721902507434 K000453 000
00721902507458 K000453 000
00721902507465 K000453 000
00721902507472 K000453 000
00721902748080 K000453 000
00721902748097 K000453 000
00721902748103 K000453 000
00721902824777 K000453 000
00885074256252 K000453 000

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