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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 K123166
Device Name TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P
Applicant
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Applicant Contact AUDREY WITKO
Correspondent
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH,  NJ  07430
Correspondent Contact AUDREY WITKO
Regulation Number888.3560
Classification Product Code
JWH  
Date Received10/09/2012
Decision Date 02/14/2013
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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