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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 ORTHOPEDICS, INC.
PMA NumberP010014
Supplement NumberS015
Date Received02/27/2007
Decision Date07/05/2007
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 changes to the process specifications for the aqueous cleaning process used during the manufacture of the components of biomet?s oxford meniscal unicompartmental knee system.
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