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FDA 510(k) Application Details - K191906
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K191906
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
MiRus, LLC
2150 Newmarket Parkway
Marietta, GA 30067 US
Other 510(k) Applications for this Company
Contact
Jordan Bauman
Other 510(k) Applications for this Contact
Regulation Number
888.3080
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Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
07/16/2019
Decision Date
05/18/2020
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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