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FDA 510(k) Application Details - K210800
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K210800
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
MiRus, LLC
1755 West Oak Parkway, Suite 100
Marietta, GA 30062 US
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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
03/16/2021
Decision Date
08/20/2021
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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