FDA 510(k) Application Details - K102324

Device Classification Name Screw, Fixation, Bone

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510(K) Number K102324
Device Name Screw, Fixation, Bone
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact SARAH HOLTGREWE
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 08/17/2010
Decision Date 05/04/2011
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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