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 IDK132994
510k NumberK132994
Device Name:ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant CORELINK LLC 1001 OAKWOOD BLVD Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
CORELINK LLC 1001 OAKWOOD BLVD Round Rock,  TX  78681
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-24
Decision Date2013-12-05
Summary:summary

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