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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 MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
Classification Nameprosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Generic Nameknee, unicompartmental, metal/polymer, cemented, mobile bearing
ApplicantBIOMET
PMA NumberP010014
Supplement NumberS012
Date Received11/16/2006
Decision Date04/23/2008
Product Code
NRA[ Registered Establishments with NRA ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the manufacturing process for a mold release agent.
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