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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 K053514
Device Name TRIATHLON TOTAL KNEE SYSTEM
Original Applicant
STRYKER ORTHOPAEDICS
325 corporate drive
mahwah,  NJ  07430
Original Contact tiffani rogers
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/16/2005
Decision Date 01/26/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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