FDA 510(k) Application Details - K120370

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

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510(K) Number K120370
Device Name Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Applicant ZIMMER, INC.
1800 WEST CENTER STREET
WARSAW, IN 46580 US
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Contact REBECCA BROOK
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Regulation Number 888.3358

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Classification Product Code OQG
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Date Received 02/06/2012
Decision Date 06/04/2012
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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