FDA 510(k) Application Details - K150661

Device Classification Name Pin, Fixation, Threaded

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510(K) Number K150661
Device Name Pin, Fixation, Threaded
Applicant CITIEFFE s.r.l
Via Armaroli 21
Calderara di Reno 400012 IT
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Contact Stefano Pullega
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Regulation Number 888.3040

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Classification Product Code JDW
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Date Received 03/13/2015
Decision Date 07/07/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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