FDA 510(k) Application Details - K172456

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

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510(K) Number K172456
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant LimaCorporate S.p.A.
Via Nazionale, 52
33038 Villanova di San Daniele
Udine IT
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Contact Michela Zanotto
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 08/14/2017
Decision Date 01/04/2018
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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