PMA P050050S023
- Device
- STAR PSI System
- Applicant
- Djo Global
- Product code
- NTG
- Decision date
- 2022-11-22
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Approval order statement
- Approval for STAR PSI System, and a new manufacturing facility at Medical Modeling, a 3D Systems Company, 5381 South Alkire Circle, Littleton, CO 80127.
Current openFDA PMA Record#
- Device
- STAR PSI System
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S023
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2022-11-22
- Decision code
- APPR
- Date received
- 2022-04-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for STAR PSI System, and a new manufacturing facility at Medical Modeling, a 3D Systems Company, 5381 South Alkire Circle, Littleton, CO 80127.