PMA P010014S031
- Device
- OXFORD PARTIAL KNEE
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S031
- Product code
- NRA
- Decision date
- 2011-07-29
- 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 LABELING CHANGES TO THE SURGICAL TECHNIQUE BROCHURE FOR THE OXFORD PARTIAL KNEE SYSTEM THAT INCLUDE THE ADDITION OF INSTRUCTIONS FOR USE FOR THE SIGNATURE PERSONALIZED PATIENT CARE SYSTEM (PATIENT-MATCHED CUTTING/DRILLING GUIDES.)
Current openFDA PMA Record#
- Device
- OXFORD PARTIAL KNEE
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S031
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2011-07-29
- Decision code
- APPR
- Date received
- 2011-05-31
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE SURGICAL TECHNIQUE BROCHURE FOR THE OXFORD PARTIAL KNEE SYSTEM THAT INCLUDE THE ADDITION OF INSTRUCTIONS FOR USE FOR THE SIGNATURE PERSONALIZED PATIENT CARE SYSTEM (PATIENT-MATCHED CUTTING/DRILLING GUIDES.)