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. |
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Device | Oxford Partial Knee |
Generic Name | Prosthesis, 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 Number | P010014 |
Supplement Number | S104 |
Date Received | 03/07/2023 |
Decision Date | 04/06/2023 |
Product Code |
NRA |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Introduction of alternative manufacturing materials that are used in Non-Destructive Testing (NDT), specifically the Fluorescent Penetrant Inspection (FPI) on the castings of Oxford Partial Knee tibial tray and twin peg femoral components. |
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