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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 K132624
Device Name TRIATHLON TRITANIUM METAL-BACKED PATELLA
Applicant
STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact SHIKHA KHANDELWAL
Correspondent
STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact SHIKHA KHANDELWAL
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received08/22/2013
Decision Date 11/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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