FDA 510(k) Application Details - K062693

Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

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510(K) Number K062693
Device Name Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact MATT PAUL
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Regulation Number 888.3390

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Classification Product Code KWY
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Date Received 09/11/2006
Decision Date 09/29/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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