PMA P010014S042
- Device
- OXFORD PARTIAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S042
- Product code
- NRA
- Decision date
- 2013-04-25
- 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
- APPROVAL TO AMEND THE IN-PROCESS INSPECTION CRITERIA USED AT THE WARSAW, INDIANA SITE, TO INCLUDE ADDITIONAL DIMENSIONAL CHECKS AFTER THE POLISHING STEP FOR THE OXFORD® TIBIAL TRAY, TO ALIGN WITH THE WARSAW FACILITY¿S STANDARD PRACTICES.
Current openFDA PMA Record#
- Device
- OXFORD PARTIAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S042
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2013-04-25
- Decision code
- APPR
- Date received
- 2013-03-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO AMEND THE IN-PROCESS INSPECTION CRITERIA USED AT THE WARSAW, INDIANA SITE, TO INCLUDE ADDITIONAL DIMENSIONAL CHECKS AFTER THE POLISHING STEP FOR THE OXFORD® TIBIAL TRAY, TO ALIGN WITH THE WARSAW FACILITY¿S STANDARD PRACTICES.