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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 K200782
Device Name Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
Applicant
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Nora O'Connor
Correspondent
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Nora O'Connor
Regulation Number888.3565
Classification Product Code
MBH  
Date Received03/26/2020
Decision Date 05/13/2020
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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