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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 K221053
Device Name Magnes-C Anterior Cervical Plate System
Applicant
Fellowship of Orthopaedic Researchers, Inc.
320 Metairie Hammond Hwy., Suite 406
Metairie,  LA  70005
Applicant Contact Stephen D. Cook
Correspondent
Backroads Consulting, Inc.
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/11/2022
Decision Date 03/01/2023
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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