FDA 510(k) Application Details - K962267

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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510(K) Number K962267
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact CRISITIE MANUEL
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Regulation Number 888.3350

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Classification Product Code JDI
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Date Received 06/13/1996
Decision Date 09/10/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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