PMA P010014S005
- Device
- OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S005
- Product code
- NRA
- Decision date
- 2007-08-03
- 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 FOR A STERILIZATION SITE LOCATED AT ISOTRON PLC, BERKSHIRE, UNITED KINGDOM.
Current openFDA PMA Record#
- Device
- OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S005
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2007-08-03
- Decision code
- APPR
- Date received
- 2005-11-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON PLC, BERKSHIRE, UNITED KINGDOM.