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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 K113254
Device Name SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS
Applicant
Lima Corporate S.P.A.
P.O. Box 696
Winona Lake,  IN  46590 -696
Applicant Contact CHERYL HASTINGS
Correspondent
Lima Corporate S.P.A.
P.O. Box 696
Winona Lake,  IN  46590 -696
Correspondent Contact CHERYL HASTINGS
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received11/03/2011
Decision Date 02/24/2012
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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