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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, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K002552
Device Name HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
Applicant
Howmedica Osteonics Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070 -2584
Applicant Contact JENNIFER A DAUDELIN
Correspondent
Howmedica Osteonics Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070 -2584
Correspondent Contact JENNIFER A DAUDELIN
Regulation Number888.3510
Classification Product Code
KRO  
Date Received08/17/2000
Decision Date 11/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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