MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD

Orthosis, Spondylolisthesis Spinal Fixation

DEPUY ACROMED

The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Monarch Spine System Commercially Pure Titanium Spinal Rod.

Pre-market Notification Details

Device IDK021148
510k NumberK021148
Device Name:MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
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 Received2002-04-10
Decision Date2002-05-08
Summary:summary

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