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FDA 510(k) Application Details - K140961
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K140961
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
Stryker Trauma AG
BOHNACKERWEG 1
SELZACH CH-2545 CH
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Contact
NESLI KARAKAYA, RAC
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/15/2014
Decision Date
11/10/2014
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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