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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTRIDENT CERAMIC ON CERAMIC ACETABULAR SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah, NJ 07430
PMA NumberP000013
Supplement NumberS006
Date Received02/22/2006
Decision Date03/14/2006
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
MANUFACTURING PROCESS CHANGES BY CERAMTEC, INC. FOR THE BIOLOX FORTE CERAMIC FEMORAL HEADS AND INSERTS.
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