PMA P050050S012
- Device
- S.T.A.R Ankle System
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S012
- Product code
- NTG
- Decision date
- 2019-10-21
- Classification
- Prosthesis, Ankle, Uncemented, Non-constrained
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Approval order statement
- Approval for a change in sealing to the packaging for the existing STAR implants.
Current openFDA PMA Record#
- Device
- S.T.A.R Ankle System
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S012
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2019-10-21
- Decision code
- APPR
- Date received
- 2018-08-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in sealing to the packaging for the existing STAR implants.