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FDA 510(k) Application Details - K151665
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K151665
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
GLOBUS MEDICAL INC.
2560 GENERAL ARMISTEAD AVE.
AUDUBON, PA 19403 US
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Contact
KELLY J BAKER
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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
06/19/2015
Decision Date
03/16/2016
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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