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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, Metal/Polymer, Porous Uncemented
510(k) Number K112158
Device Name MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
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 Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWY   KWZ  
Date Received07/27/2011
Decision Date 05/10/2012
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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