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FDA 510(k) Application Details - K221324
Device Classification Name
More FDA Info for this Device
510(K) Number
K221324
Device Name
ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
Applicant
Camber Spine Technologies
501 Allendale Road
King of Prussia, PA 19406 US
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Contact
Noel Hetrick
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVD
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More FDA Info for this Product Code
Date Received
05/06/2022
Decision Date
03/30/2023
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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