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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 K191757
Device Name EUROPA Pedicle Screw System
Applicant
MiRus, LLC
2150 Newmarket Pkwy.
Marietta,  GA  30067
Applicant Contact Jordan Bauman
Correspondent
MiRus, LLC
2150 Newmarket Pkwy.
Marietta,  GA  30067
Correspondent Contact Jordan Bauman
Regulation Number888.3070
Classification Product Code
NKB  
Date Received07/01/2019
Decision Date 07/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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