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FDA 510(k) Application Details - K130977
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K130977
Device Name
Filler, Bone Void, Calcium Compound
Applicant
GLOBUS MEDICAL INC.
2560 GENERAL ARMISTEAD AVE.
AUDUBON, PA 19403 US
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Contact
SARAH MARIE FITZGERALD
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/09/2013
Decision Date
12/24/2013
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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