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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 NumberS001
Date Received02/04/2003
Decision Date03/17/2003
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following items: 1) use of the trident acetabular system with v40 alumina heads and additional c-taper alumina head sizes (and associated stems) 2) use of the trident acetabular system with v40/c-taper and morse taper adapter sleeves (and associated femoral stems) 3) use of additional styles of trident acetabular shells; and 4) associated labeling changes due to modifications identified above.
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