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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOXFORD MENISCAL UNICOMPARTMENTAL KNEE
Classification Nameprosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, IN 46581-0587
PMA NumberP010014
Supplement NumberS017
Date Received08/22/2007
Decision Date02/20/2008
Product Code
NRA[ Registered Establishments with NRA ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR A PRODUCT LINE EXTENSION TO INCLUDE A NEW SERIES OF FEMORAL COMPONENTS DESIGNED TO ADD AN ADDITIONAL FIXATION PEG AND EXTEND THE ARTICULAR SURFACE 20 DEGREES ANTERIORLY.
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