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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 NumberS009
Date Received04/16/2009
Decision Date05/07/2009
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the labeling (i. E. , surgical protocol) of the trident hip system. These modifications include creating separate and distinct surgical protocols, one for the trident psl shell and one for the trident hemispherical shell, in order to clarify the differences in reaming techniques between the two shells, as well as other improvements to the surgical protocol.
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