CONCORDE CURVE SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

JOHNSON & JOHNSON

The following data is part of a premarket notification filed by Johnson & Johnson with the FDA for Concorde Curve System.

Pre-market Notification Details

Device IDK103743
510k NumberK103743
Device Name:CONCORDE CURVE SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham,  MA  02767 -0151
ContactEugene Bang
CorrespondentEugene Bang
JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham,  MA  02767 -0151
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-23
Decision Date2011-03-17
Summary:summary

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