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PMA P010014S104

Device
Oxford Partial Knee
Applicant
Biomet Manufacturing Corp
PMA number
P010014
Supplement
S104
Product code
NRA
Decision date
2023-04-06
Classification
Orthopedic
Generic name
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
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.

Current openFDA PMA Record#

Device
Oxford Partial Knee
Applicant
Biomet Manufacturing Corp
PMA number
P010014
Supplement
S104
Product code
NRA
Generic name
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date
2023-04-06
Decision code
OK30
Date received
2023-03-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.