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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K123486
Device Name TRIATHLON TRITANIUM TIBIAL BASEPLATE
Applicant
Stryker
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact AUDREY WITKO
Correspondent
Stryker
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact AUDREY WITKO
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received11/13/2012
Decision Date 05/03/2013
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
Recalls CDRH Recalls
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