CONCORDE BULLET SPINAL 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 Bullet Spinal System.

Pre-market Notification Details

Device IDK110694
510k NumberK110694
Device Name:CONCORDE BULLET SPINAL SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham,  MA  02767 -0151
ContactDaphney Germain-kolawole
CorrespondentDaphney Germain-kolawole
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 Received2011-03-14
Decision Date2011-10-11
Summary:summary

NIH GUDID Devices

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