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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
510(k) Number K110940
Device Name ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact CAROL VIERLING
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact CAROL VIERLING
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LPH  
LWJ   LZO  
Date Received04/04/2011
Decision Date 07/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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