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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 K190402
Device Name Triathlon Total Knee System-Additional Components
Applicant
Stryker Orthopaedics (aka Howmedica Osteonics Corp.)
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Margaret Crowe Klippel
Correspondent
Stryker Orthopaedics (aka Howmedica Osteonics Corp.)
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Margaret Crowe Klippel
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received02/19/2019
Decision Date 08/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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