FDA 510(k) Application Details - K201715

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K201715
Device Name Pin, Fixation, Smooth
Applicant Stryker GmbH
325 Corporate Drive
Mahwah, NJ 07430 US
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Contact Jemin Dedania
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 06/23/2020
Decision Date 08/05/2020
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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