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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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K042993
Device Name TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT
Applicant
HOWMEDICA OSTEONICS CORP
325 COMMERCE COURT
MAHWAH,  NJ  07430
Applicant Contact DENISE DUCHENE
Correspondent
HOWMEDICA OSTEONICS CORP
325 COMMERCE COURT
MAHWAH,  NJ  07430
Correspondent Contact DENISE DUCHENE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/01/2004
Decision Date 01/12/2005
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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