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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 NumberS043
Date Received04/22/2013
Decision Date06/25/2013
Product Code
NRA[ Registered Establishments with NRA ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOMET, INC., WARSAW, INDIANA, FOR MANUFACTURING OF THE MENISCAL BEARINGS.
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