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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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K050723
Device Name MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS
Applicant
ZIMMER, INC.
345 E. MAIN ST.
WARSAW,  IN  46580
Applicant Contact TONI KINGSLEY
Correspondent
ZIMMER, INC.
345 E. MAIN ST.
WARSAW,  IN  46580
Correspondent Contact TONI KINGSLEY
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/21/2005
Decision Date 04/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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