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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, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K223528
Device Name Triathlon® Hinge Knee System
Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact Allison Byrne
Correspondent
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact Allison Byrne
Regulation Number888.3510
Classification Product Code
KRO  
Date Received11/23/2022
Decision Date 01/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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