CD HORIZON SPINAL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

DANEK MEDICAL, INC.

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

Pre-market Notification Details

Device IDK993810
510k NumberK993810
Device Name:CD HORIZON SPINAL SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis,  TN  38132
ContactRichard W Treharne
CorrespondentRichard W Treharne
DANEK MEDICAL, INC. 1800 PYRAMID PL. 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 Received1999-11-10
Decision Date2000-02-03
Summary:summary

NIH GUDID Devices

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