Premarket Approval (PMA)
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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 Partial Knee System
Generic Nameprosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
ApplicantBIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, IN 46581-0587
PMA NumberP010014
Supplement NumberS079
Date Received06/19/2018
Decision Date07/17/2018
Product Code NRA 
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Transfer testing of tensile mechanical properties of Oxford Partial Knee UHMWPE bearing test specimens to ATS Labs, Zimmer Inc.
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