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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K190991
Device Name Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
Applicant
Howmedica Osteonics Corp. (aka Stryker Orthopaedics)
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Dipan Lad
Correspondent
Howmedica Osteonics Corp. (aka Stryker Orthopaedics)
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Dipan Lad
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received04/15/2019
Decision Date 08/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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