FDA 510(k) Application Details - K233741

Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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510(K) Number K233741
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant Stryker GmbH
Bohnackerweg 1
CH-2545
Selzach CH
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Contact Amy Noccioli
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Regulation Number 888.3030

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Classification Product Code KTT
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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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