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FDA 510(k) Application Details - K233741
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K233741
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
Stryker GmbH
Bohnackerweg 1
CH-2545
Selzach CH
Other 510(k) Applications for this Company
Contact
Amy Noccioli
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
11/22/2023
Decision Date
12/21/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K233741
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