FDA 510(k) Application Details - K123019

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

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510(K) Number K123019
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant ZIMMER, INC.
1800 WEST CENTER STREET
WARSAW, IN 46580 US
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Contact REBECCA BROOKS
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 09/28/2012
Decision Date 10/22/2012
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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