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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
510(k) Number K120370
Device Name VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
Applicant
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Applicant Contact REBECCA BROOK
Correspondent
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Correspondent Contact REBECCA BROOK
Regulation Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
JDI   LPH   LZO   OQH   OQI  
Date Received02/06/2012
Decision Date 06/04/2012
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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