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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 NumberS024
Date Received08/03/2012
Decision Date09/06/2012
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an independent inspector to perform visual check of the s-rom femoral stem component sterile packaging.
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