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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, Lumbar
510(k) Number K220115
Device Name ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System
Applicant
MiRus, LLC
1755 West Oak Parkway, Suite 100
Marietta,  GA  30062
Applicant Contact Jordan Bauman
Correspondent
MiRus, LLC
1755 West Oak Parkway, Suite 100
Marietta,  GA  30062
Correspondent Contact Jordan Bauman
Regulation Number888.3080
Classification Product Code
OVD  
Date Received01/14/2022
Decision Date 05/13/2022
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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