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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K182970
Device Name EUROPA™ Pedicle Screw System
Applicant
MiRus, LLC
2150 Newmarket Pkwy.
Suite 108
Marietta,  GA  30067
Applicant Contact Jordan Bauman
Correspondent
MiRus, LLC
2150 Newmarket Pkwy. SE
Suite 108
Marietta,  GA  30067
Correspondent Contact Jordan Bauman
Regulation Number888.3070
Classification Product Code
NKB  
Date Received10/26/2018
Decision Date 01/22/2019
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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