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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, Hemi-, Humeral, Metallic Uncemented
510(k) Number K112900
Device Name SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
Applicant
Lima Corporate S.P.A.
P.O. Box 696
Winona Lake,  IN  46590
Applicant Contact CHERYL HASTINGS
Correspondent
Lima Corporate S.P.A.
P.O. Box 696
Winona Lake,  IN  46590
Correspondent Contact CHERYL HASTINGS
Regulation Number888.3690
Classification Product Code
HSD  
Subsequent Product Code
KWS  
Date Received10/03/2011
Decision Date 06/01/2012
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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