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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K112091
Device Name H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR 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 Number888.3353
Classification Product Code
MEH  
Subsequent Product Code
JDI  
Date Received07/21/2011
Decision Date 11/09/2012
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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