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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 K230952
Device Name Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component
Applicant
Howmedica Osteonics Corp. dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Jane Guo
Correspondent
Howmedica Osteonics Corp. dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Jane Guo
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/04/2023
Decision Date 06/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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