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FDA 510(k) Application Details - K210595
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
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510(K) Number
K210595
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Camber Spine Technologies, LLC
501 Allendale Road
King of Prussia, PA 19604 US
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Contact
Donald W. Guthner
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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
03/01/2021
Decision Date
06/15/2021
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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