MONET Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

CTL Medical Corporation

The following data is part of a premarket notification filed by Ctl Medical Corporation with the FDA for Monet Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK220334
510k NumberK220334
Device Name:MONET Anterior Cervical Plate System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant CTL Medical Corporation 4550 Excel Pkwy Ste 300 Addison,  TX  75001
ContactSean Suh
CorrespondentDhaval Saraiya
Omni Strategic Solutions, LLC 700 Pennsylvania Ave SE 2nd Floor Washington,  DC  20003
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-04
Decision Date2022-11-09

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