CD HORIZON SPINAL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

MEDTRONIC SOFAMOR DANEK

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

Pre-market Notification Details

Device IDK061915
510k NumberK061915
Device Name:CD HORIZON SPINAL SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard Treharne
CorrespondentRichard Treharne
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNI
Subsequent Product CodeNKB
Subsequent Product CodeNQP
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-06
Decision Date2006-07-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994729590 K061915 000
00613994234735 K061915 000
00613994177193 K061915 000

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