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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 K230416
Device Name Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Allison Byrne
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Allison Byrne
Regulation Number888.3510
Classification Product Code
Subsequent Product Code
Date Received02/16/2023
Decision Date 05/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No