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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 NameOXFORD PARTIAL KNEE SYSTEM
Classification Nameprosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Generic Nameknee, unicompartmental, metal/polymer, cemented, mobile bearing
ApplicantBIOMET, INC.
PMA NumberP010014
Supplement NumberS028
Date Received11/09/2010
Decision Date01/07/2011
Product Code
NRA[ Registered Establishments with NRA ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the package insert, including the addition of mr conditional labeling and the associated mr conditions of use.
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