FDA 510(k) Application Details - K082673

Device Classification Name Prosthesis, Hip, Femoral, Resurfacing

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510(K) Number K082673
Device Name Prosthesis, Hip, Femoral, Resurfacing
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact THERESA LEISTER
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Regulation Number 888.3400

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Classification Product Code KXA
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Date Received 09/15/2008
Decision Date 12/12/2008
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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