FDA 510(k) Application Details - K132895

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K132895
Device Name Pin, Fixation, Smooth
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact LESLIE FITCH
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 09/16/2013
Decision Date 10/23/2013
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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