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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K232348
Device Name RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion 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 Number888.3080
Classification Product Code
OVE  
Date Received08/07/2023
Decision Date 10/27/2023
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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