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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 K050556
Device Name ALUMINA HEAD
Applicant
Fournitures Hospitalieres Industrie
Zi De Kernevez-6 Rue Nobel
Quimper Finistere,  FR 29000
Applicant Contact CHRISTINE QUENDEZ
Correspondent
Fournitures Hospitalieres Industrie
Zi De Kernevez-6 Rue Nobel
Quimper Finistere,  FR 29000
Correspondent Contact CHRISTINE QUENDEZ
Regulation Number888.3353
Classification Product Code
LZO  
Date Received03/03/2005
Decision Date 05/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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