CD HORIZON SPINAL SYSTEM

Posterior Metal/polymer Spinal System, Fusion

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 IDK061304
510k NumberK061304
Device Name:CD HORIZON SPINAL SYSTEM
ClassificationPosterior Metal/polymer Spinal System, Fusion
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard Treharne
CorrespondentRichard Treharne
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeNQP  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeNKB
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-10
Decision Date2006-07-18
Summary:summary

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