FDA 510(k) Application Details - K072417

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

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510(K) Number K072417
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS, TN 38116 US
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Contact RISHI SINHA
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 08/28/2007
Decision Date 01/10/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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