PMA P050050S022
- Device
- Scandinavian Total Ankle Replacement (STAR Ankle)
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S022
- Product code
- NTG
- Decision date
- 2022-03-11
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Approval order statement
- Replacing a sub-supplier of folded boxes for STAR Ankle implant components.
Current openFDA PMA Record#
- Device
- Scandinavian Total Ankle Replacement (STAR Ankle)
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S022
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2022-03-11
- Decision code
- OK30
- Date received
- 2022-02-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacing a sub-supplier of folded boxes for STAR Ankle implant components.