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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K142139
Device Name SMR 40MM GLENOSPHERE
Applicant
Lima Corporate S.P.A.
5010 Lodge Pole Ln.
Fort Wayne,  IN  46814
Applicant Contact STEPHEN PEOPLES
Correspondent
Lima Corporate S.P.A.
5010 Lodge Pole Ln.
Fort Wayne,  IN  46814
Correspondent Contact STEPHEN PEOPLES
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received08/05/2014
Decision Date 11/07/2014
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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