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PMA P010014S098

Device
Oxford Partial Knee System
Applicant
Biomet Manufacturing Corp
Product code
NRA
Decision date
2021-12-17
Generic name
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Approval for the introduction of a new instructions for use (IFU) for cleaning, disinfection and sterilization of the reusable Oxford Partial Knee instruments.

Current openFDA PMA Record#

Device
Oxford Partial Knee System
Applicant
Biomet Manufacturing Corp
PMA number
P010014
Supplement
S098
Product code
NRA
Generic name
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date
2021-12-17
Decision code
APPR
Date received
2019-12-06
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for the introduction of a new instructions for use (IFU) for cleaning, disinfection and sterilization of the reusable Oxford Partial Knee instruments.