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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, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K180612
Device Name Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
Applicant
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact Emily DiMambro
Correspondent
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact Emily DiMambro
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Codes
HRY   NPJ  
Date Received03/08/2018
Decision Date 06/07/2018
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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