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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
510(k) Number K191963
Device Name SMR Finned Short Stems
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
Villanova Di San Daniele Del Friuli,  IT 33038
Applicant Contact Giuseppe Valenti
Correspondent
Peoples & Associates Consulting, LLC
5010 Lodge Pole Ln.
Fort Wayne,  IN  46814
Correspondent Contact Stephen Peoples
Regulation Number888.3670
Classification Product Code
MBF  
Subsequent Product Codes
HSD   KWS   KWT   PHX  
Date Received07/23/2019
Decision Date 10/10/2019
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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