MODIFICATION TO: CD HORIZON SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

MEDTRONIC SOFAMOR DANEK

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

Pre-market Notification Details

Device IDK040583
510k NumberK040583
Device Name:MODIFICATION TO: CD HORIZON SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle 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 CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeNKB
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-05
Decision Date2004-03-31
Summary:summary

NIH GUDID Devices

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