FDA 510(k) Application Details - K141043

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

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510(K) Number K141043
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant Consensus Orthopedics, Inc
1115 WINFIELD WAY
SUITE 100
EL DORADO HILLS, CA 95762-9623 US
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Contact MATTHEW M HULL
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 04/23/2014
Decision Date 05/19/2014
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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