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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 K201343
Device Name Triathlon Total KneeSystem
Applicant
Howmedica Osteonics Corp. dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Shikha Khandelwal
Correspondent
Howmedica Osteonics Corp. dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Shikha Khandelwal
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received05/20/2020
Decision Date 07/10/2020
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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