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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
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 NumberS042
Date Received03/27/2013
Decision Date04/25/2013
Product Code
NRA[ Registered Establishments with NRA ]
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL TO AMEND THE IN-PROCESS INSPECTION CRITERIA USED AT THE WARSAW, INDIANA SITE, TO INCLUDE ADDITIONAL DIMENSIONAL CHECKS AFTER THE POLISHING STEP FOR THE OXFORD® TIBIAL TRAY, TO ALIGN WITH THE WARSAW FACILITY¿S STANDARD PRACTICES.
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