CD HORIZON SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

MEDTRONIC SOFAMOR DANEK USA, INC.

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

Pre-market Notification Details

Device IDK051674
510k NumberK051674
Device Name:CD HORIZON SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard Treharne
CorrespondentRichard Treharne
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeNQP
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-23
Decision Date2005-07-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994130556 K051674 000
00613994130549 K051674 000
00613994130532 K051674 000
00613994130525 K051674 000
00613994130518 K051674 000
00885074445380 K051674 000

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