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FDA 510(k) Application Details - K220115
Device Classification Name
More FDA Info for this Device
510(K) Number
K220115
Device Name
ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System
Applicant
MiRus, LLC
1755 West Oak Parkway, Suite 100
Marietta, GA 30062 US
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Contact
Jordan Bauman
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Regulation Number
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Classification Product Code
OVD
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More FDA Info for this Product Code
Date Received
01/14/2022
Decision Date
05/13/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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