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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 K001548
Device Name MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
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 Received05/18/2000
Decision Date 06/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
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