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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 K172326
Device Name Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
Applicant
Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Margaret Klippel
Correspondent
Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Margaret Klippel
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
HRY   HSX   KRR   MBH   NPJ  
Date Received08/01/2017
Decision Date 10/30/2017
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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