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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 K101263
Device Name LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,
Applicant
Lima-Lto S.P.A.
P.O. Box 696
Winona Lake,  IN  46590
Applicant Contact CHERYL HASTINGS
Correspondent
Lima-Lto S.P.A.
P.O. Box 696
Winona Lake,  IN  46590
Correspondent Contact CHERYL HASTINGS
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Code
HSD  
Date Received05/05/2010
Decision Date 01/28/2011
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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