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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K190415
Device Name ATLAS Plating System
Applicant
Mirus, LLC
2150 Newmarket Pkwy.
Suite 108
Marietta,  GA  30067
Applicant Contact Jordan Bauman
Correspondent
Mirus, LLC
2150 Newmarket Pkwy.
Suite 108
Marietta,  GA  30067
Correspondent Contact Jordan Bauman
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/21/2019
Decision Date 04/19/2019
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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