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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDURALOC OPTION CERAMIC HIP SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, IN 46581-0988
PMA NumberP040023
Supplement NumberS024
Date Received08/03/2012
Decision Date09/06/2012
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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