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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 (OXFORD PARTIAL 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 NumberS024
Date Received09/10/2009
Decision Date03/17/2010
Product Code NRA 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR NEW HEATING EQUIPMENT BEING INTRODUCED TO SEAL BLISTER PACKAGES, WHICH CONTAIN THE OXFORD® PARTIAL KNEE IMPLANTS.
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