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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 K203099
Device Name Triathlon PKR System
Applicant
Howmedica Osteonics Corp aka Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact Allison Byrne
Correspondent
Howmedica Osteonics Corp aka Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact Allison Byrne
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Codes
HRY   KRR   NPJ  
Date Received10/14/2020
Decision Date 10/27/2020
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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