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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 K151739
Device Name Revision Femoral Stem
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
Villanova Di San Daniele Del Friuli,  IT 33038
Applicant Contact EMANUELE BUTTAZZONI
Correspondent
Peoples & 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 Received06/26/2015
Decision Date 11/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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