PMA P050050S006
- Device
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM STAR ANKLE
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S006
- Product code
- NTG
- Decision date
- 2014-06-04
- Classification
- Prosthesis, Ankle, Uncemented, Non-constrained
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Approval order statement
- APPROVAL FOR CHANGING THE INNER POUCH MATERIAL FOR THE STAR SLIDING CORE COMPONENT.
Current openFDA PMA Record#
- Device
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM STAR ANKLE
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S006
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2014-06-04
- Decision code
- APPR
- Date received
- 2014-03-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGING THE INNER POUCH MATERIAL FOR THE STAR SLIDING CORE COMPONENT.