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FDA 510(k) Application Details - K172438
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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510(K) Number
K172438
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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
888.3030
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Classification Product Code
KTT
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More FDA Info for this Product Code
Date Received
08/11/2017
Decision Date
01/12/2018
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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