MODIFICATION TO MONARCH SPINE SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

DEPUY ACROMED

The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Modification To Monarch Spine System.

Pre-market Notification Details

Device IDK023438
510k NumberK023438
Device Name:MODIFICATION TO MONARCH SPINE SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant DEPUY ACROMED 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactLisa Gilman
CorrespondentLisa Gilman
DEPUY ACROMED 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-15
Decision Date2002-11-13
Summary:summary

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