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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 K182920
Device Name MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF)
Applicant
MiRus, LLC
2150 Newmarket Parkway
Marietta,  GA  30067
Applicant Contact Jordan Bauman
Correspondent
MiRus, LLC
2150 Newmarket Parkway SE, Suite 108
Marietta,  GA  30067
Correspondent Contact Jordan Bauman
Regulation Number888.3080
Classification Product Code
MAX  
Date Received10/19/2018
Decision Date 03/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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