FDA 510(k) Application Details - K151739

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

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510(K) Number K151739
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Applicant LIMACORPORATE S.P.A.
VIA NAZIONALE 52
VILLANOVA DI SAN DANIELE 33038 IT
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Contact EMANUELE BUTTAZZONI
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Regulation Number 888.3353

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Classification Product Code LZO
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Date Received 06/26/2015
Decision Date 11/23/2015
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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