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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K020989
Device Name SUPER EON PLUS FEMORAL STEMS
Applicant
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE,  NJ  07401 -1677
Applicant Contact JENNIFER A DAUDELIN
Correspondent
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE,  NJ  07401 -1677
Correspondent Contact JENNIFER A DAUDELIN
Regulation Number888.3350
Classification Product Code
JDI  
Date Received03/27/2002
Decision Date 04/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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