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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K220334
Device Name MONET Anterior Cervical Plate System
Applicant
Ctl Medical Corporation
4550 Excel Pkwy.
Suite 300
Addison,  TX  75001
Applicant Contact Sean Suh
Correspondent
Omni Strategic Solutions, LLC
700 Pennsylvania Ave. SE
2nd Floor
Washington,  DC  20003
Correspondent Contact Dhaval Saraiya
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/04/2022
Decision Date 11/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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