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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 NameDURALOC OPTION CERAMIC HIP SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nametotal hip system,ceramic articulation
ApplicantDEPUY ORTHOPAEDICS, INC.
PMA NumberP040023
Supplement NumberS007
Date Received05/04/2006
Decision Date05/26/2006
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 an additional label being added to the device outer package that states, "warning: only compatible with option series implants".
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