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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 K072221
Device Name MODIFICATION TO TRIATHLON TS KNEE SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP.
325 CORPORATE DR
MAHWAH,  NJ  07430
Applicant Contact TIFFANI ROGERS
Correspondent
HOWMEDICA OSTEONICS CORP.
325 CORPORATE DR
MAHWAH,  NJ  07430
Correspondent Contact TIFFANI ROGERS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/10/2007
Decision Date 10/15/2007
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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