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FDA 510(k) Application Details - K131449
Device Classification Name
More FDA Info for this Device
510(K) Number
K131449
Device Name
COALITION SPACER
Applicant
GLOBUS MEDICAL, INC.
2560 General Armistead Ave
VALLEY FORGE BUSINESS CENTER
AUDUBON, PA 19403 US
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Contact
CHRISTINA KICHULA
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Regulation Number
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Classification Product Code
OVE
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More FDA Info for this Product Code
Date Received
05/20/2013
Decision Date
07/30/2013
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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