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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 K210800
Device Name IO Expandable Lumbar Interbody Fusion System
Applicant
MiRus, LLC
1755 West Oak Parkway, Suite 100
Marietta,  GA  30062
Applicant Contact Jordan Bauman
Correspondent
MiRus, LLC
1755 West Oak Parkway, Suite 100
Marietta,  GA  30062
Correspondent Contact Jordan Bauman
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/16/2021
Decision Date 08/20/2021
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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