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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, Non-Constrained, Metal/Polymer Cemented
510(k) Number K161476
Device Name SMR Shoulder System
Applicant
Lima Corporate S.P.A.
Via Nazionale, 52 Villanova Di San Daniele
Udine,  IT 33038
Applicant Contact Sara Viel
Correspondent
Lima Corporate S.P.A.
Via Nazionale, 52 Villanova Di San Daniele
Udine,  IT 33038
Correspondent Contact Stephen J. Peoples
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Code
HSD  
Date Received05/27/2016
Decision Date 06/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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