MODIFICATION TO: 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 Modification To: Cd Horizon Spinal System.

Pre-market Notification Details

Device IDK043343
510k NumberK043343
Device Name:MODIFICATION TO: 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
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-06
Decision Date2004-12-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994130518 K043343 000

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