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 IDK041030
510k NumberK041030
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
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-21
Decision Date2004-06-30
Summary:summary

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