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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Wedge
510(k) Number K252733
Device Name ATLAS™ Expandable Osteotomy Wedge System
Applicant
MiRus, LLC
1755 W. Oak Pkwy.
Suite 100
Marietta,  GA  30062
Applicant Contact Anuradha Nagulapati
Correspondent
MiRus, LLC
1755 W. Oak Pkwy.
Suite 100
Marietta,  GA  30062
Correspondent Contact Anuradha Nagulapati
Regulation Number888.3030
Classification Product Code
PLF  
Date Received08/28/2025
Decision Date 02/19/2026
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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