FDA 510(k) Application Details - K242445

Device Classification Name Plate, Fixation, Bone

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510(K) Number K242445
Device Name Plate, Fixation, Bone
Applicant Stryker GmbH
Bohnackerweg 1
Selzach 2545 CH
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Contact Ashley Allison
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 08/16/2024
Decision Date 10/06/2024
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

FDA Source Information for K242445


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