PMA P010014S073
- Device
- Oxford Patrial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S073
- Product code
- NRA
- Decision date
- 2018-04-19
- Classification
- Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Change the laboratory that is conducting microbiology tests, change the irradiator vendor used for irradiating dose verification of test samples, and change the vendor used for testing water conductivity.
Current openFDA PMA Record#
- Device
- Oxford Patrial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S073
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2018-04-19
- Decision code
- OK30
- Date received
- 2018-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the laboratory that is conducting microbiology tests, change the irradiator vendor used for irradiating dose verification of test samples, and change the vendor used for testing water conductivity.