PMA P050050S010
- Device
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R. ANKLE)
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S010
- Product code
- NTG
- Decision date
- 2016-09-28
- Classification
- Prosthesis, Ankle, Uncemented, Non-constrained
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Approval order statement
- Approval for the use of three specific saw blades in the S.T.A.R. ankle surgical technique.
Current openFDA PMA Record#
- Device
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R. ANKLE)
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S010
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2016-09-28
- Decision code
- APPR
- Date received
- 2016-07-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the use of three specific saw blades in the S.T.A.R. ankle surgical technique.