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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K242516
Device Name EUROPA™ Posterior Cervical Fusion System
Applicant
MiRus, LLC
1755 W. Oak Parkway
Suite 100
Marietta,  GA  30062
Applicant Contact Anuradha Nagulapati
Correspondent
MiRus, LLC
1755 W. Oak Parkway
Suite 100
Marietta,  GA  30062
Correspondent Contact Anuradha Nagulapati
Regulation Number888.3075
Classification Product Code
NKG  
Date Received08/23/2024
Decision Date 11/19/2024
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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