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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 K161226
Device Name Revision Femoral Stem
Applicant
LIMACORPORATE S.P.A.
VIA NAZIONALE 52
VILLANOVA DI SAN DANIELE,  IT 33038
Applicant Contact EMANUELE BUTTAZZONI
Correspondent
PEOPLE & ASSOCIATES- STEPHEN J. PEOPLES, VMD, MS
411 AUDITORIUM BLVD.
WINONA LAKE,  IN  46590
Correspondent Contact STEPHEN PEOPLES
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LPH  
Date Received05/02/2016
Decision Date 02/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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