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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameOSTEONICS ABC/TRIDENT SYSTEMS
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantHOWMEDICA OSTEONICS CORP.
PMA NumberP000013
Supplement NumberS004
Date Received04/15/2004
Decision Date08/16/2004
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the trident "t" shell for use with the trident alumina insert. The trident "t" shell, which features a thicker shell wall, is a line extension to the trident acetabular shells previously approved for use with the trident alumina insert.
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