CONCORDE Bullet Lumbar Interbody System

Intervertebral Fusion Device With Bone Graft, Lumbar

Medos International, Sarl

The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Concorde Bullet Lumbar Interbody System.

Pre-market Notification Details

Device IDK151773
510k NumberK151773
Device Name:CONCORDE Bullet Lumbar Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medos International, Sarl Chemin-Blanc 38 Le Locle,  CH 2400
ContactJaclyn Porsolt
CorrespondentJaclyn Porsolt
DePuy Spine, A Johnson & Johnson Company 325 Paramount Drive Raynham,  MA  02767
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-30
Decision Date2015-11-20
Summary:summary

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