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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K143509
Device Name MasterSL femoral stem
Applicant
LIMACORPORATE S.P.A.
VIA NAZIONALE, 52
VILLANOVA DI SAN DANIELE,  IT 33038
Applicant Contact STEPHEN J PEOPLES
Correspondent
LIMACORPORATE S.P.A.
5010 Lodge Pole Lane
Fort Wayne,  IN  46814
Correspondent Contact Stephen Peoples
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWY   KWZ   LPH  
Date Received12/11/2014
Decision Date 01/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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