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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, INC.
PMA NumberP010014
Supplement NumberS022
Date Received10/24/2008
Decision Date11/21/2008
Product Code
NRA[ Registered Establishments with NRA ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a check of thickness prior to engraving of the meniscal bearing components of the biomet oxford meniscal unicompartmental knew system to prevent components from being mis-engraved.
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