PMA P010014S027
- Device
- OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S027
- Product code
- NRA
- Decision date
- 2010-08-31
- 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 OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S027
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2010-08-31
- Decision code
- APPR
- Date received
- 2010-07-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.