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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 K052718
FOIA Releasable 510(k) K052718
Device Name V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
Applicant
Howmedica Osteonics Corp.
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact KAREN ARIEMMA
Correspondent
Howmedica Osteonics Corp.
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact KAREN ARIEMMA
Regulation Number888.3353
Classification Product Code
LZO  
Date Received09/29/2005
Decision Date 10/27/2005
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
Recalls CDRH Recalls
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