FDA 510(k) Application Details - K063822

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

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510(K) Number K063822
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah, NJ 07430 US
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Contact TIFFANI ROGERS
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 12/26/2006
Decision Date 01/25/2007
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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