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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 K170473
Device Name C2 femoral stem
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
Villanova Di San Daniele Del Friuli,  IT 33038
Applicant Contact Antonio Soleti
Correspondent
Peoples & Associates - Stephen J. Peoples, Vmd, MS
5010 Lodge Pole Ln.
Fort Wayne,  IN  46814
Correspondent Contact Stephen Peoples
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LWJ  
Date Received02/16/2017
Decision Date 11/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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