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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K253444
Device Name EUROPA™ Posterior Cervical Fusion Navigated Instruments
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 Number882.4560
Classification Product Code
OLO  
Date Received10/02/2025
Decision Date 03/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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