FDA 510(k) Application Details - K170418

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K170418
Device Name Pin, Fixation, Smooth
Applicant Stryker Trauma Gmbh
Prof-Kuentscher-Str. 1-5
Schoenkirchen 24232 DE
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Contact Heike Gustke
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 02/13/2017
Decision Date 06/20/2017
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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