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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 K973121
Device Name INTERAX TOTAL KNEE SYSTEM
Applicant
HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070
Applicant Contact MARGARET F CROWE
Correspondent
HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070
Correspondent Contact MARGARET F CROWE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/20/1997
Decision Date 11/18/1997
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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