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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
Classification Nameprosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Generic Nameknee, unicompartmental, metal/polymer, cemented, mobile bearing
ApplicantBIOMET
PMA NumberP010014
Supplement NumberS009
Date Received07/03/2006
Decision Date07/18/2006
Product Code
NRA[ Registered Establishments with NRA ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the process specifications for the 9-stage kerry cleaning plant used in the ultrasonic cleaning of the oxford meniscal unicompartmental knee system metallic components (femoral and tibial). The changes require detailed monitoring of the ultrasonic equipment to ensure the adequacy of its output.
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