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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 K220441
Device Name CYGNUS™ MoRe Anterior Cervical Plate System
Applicant
Mirus, LLC
1755 W. Oak Pkwy.
Suite 100
Marietta,  GA  30062
Applicant Contact Jordan Bauman
Correspondent
Mirus, LLC
1755 W. Oak Pkwy.
Suite 100
Marietta,  GA  30062
Correspondent Contact Jordan Bauman
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/16/2022
Decision Date 09/16/2022
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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