FDA 510(k) Application Details - K051741

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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510(K) Number K051741
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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 888.3353

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Classification Product Code LZO
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Date Received 06/28/2005
Decision Date 09/26/2005
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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