Azure Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

ORTHOFIX, INC.

The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for Azure Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK143028
510k NumberK143028
Device Name:Azure Anterior Cervical Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant ORTHOFIX, INC. 3451 PLANO PARKWAY Lewisville,  TX  75056
ContactNatalia Volosen
CorrespondentNatalia Volosen
ORTHOFIX, INC. 3451 PLANO PARKWAY Lewisville,  TX  75056
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-21
Decision Date2015-05-29

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