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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 SYSTEM
Generic NameProsthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
ApplicantBiomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw, IN 46581
PMA NumberP010014
Supplement NumberS039
Date Received11/05/2012
Decision Date01/04/2013
Product Code NRA 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
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