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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 NameCORMET HIP RESURFACING SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/metal, resurfacing
Generic Namemetal-on-metal hip resurfacing system
ApplicantCORIN U.S.A.
PMA NumberP050016
Supplement NumberS009
Date Received02/23/2012
Decision Date03/22/2013
Product Code
NXT[ Registered Establishments with NXT ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the reprocessing of unused cormet resurfacing heads that are approaching their expiration date. The unused cormet resurfacing heads will be opened from the packaging, cleaned, repacked, re-sterilized and relabeled with a 5 year shelf life.
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