ANODYNE ANTERIOR CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

CORELINK LLC

The following data is part of a premarket notification filed by Corelink Llc with the FDA for Anodyne Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK121514
510k NumberK121514
Device Name:ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant CORELINK LLC 1331 H STREET 12TH FLOOR Washington,  DC  20005
ContactJustin Eggleton
CorrespondentJustin Eggleton
CORELINK LLC 1331 H STREET 12TH FLOOR Washington,  DC  20005
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-22
Decision Date2012-12-14
Summary:summary

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