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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K191906
Device Name MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
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 Number888.3080
Classification Product Code
MAX  
Date Received07/16/2019
Decision Date 05/18/2020
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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