- Device
- Scandinavian Total Ankle Replacement (STAR Ankle)
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S017
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2021-03-15
- Decision code
- OK30
- Date received
- 2021-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in sub-suppliers for the citric passivation steps for the STAR Pin Tube (727-0001-01) and the STAR Pin Tube Cap (727-0001-02) components.