FDA 510(k) Application Details - K150855

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

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510(K) Number K150855
Device Name Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Applicant Limacorporate S.P.A.
Via Nazionale, 52
Villanova di San Daniele 33038 IT
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Contact Sara Viel
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Regulation Number 888.3353

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Classification Product Code MEH
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Date Received 03/31/2015
Decision Date 10/21/2015
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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