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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K022403
Device Name GMRS PRESS FIT STEMS WITH PUREFIX HA
Applicant
Howmedica Osteonics Corp.
59 Rte. 17 S.
Allendale,  NJ  07401
Applicant Contact MARGARET F CROWE
Correspondent
Howmedica Osteonics Corp.
59 Rte. 17 S.
Allendale,  NJ  07401
Correspondent Contact MARGARET F CROWE
Regulation Number888.3353
Classification Product Code
LZO  
Date Received07/23/2002
Decision Date 10/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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