PMA P050050S021
- Device
- Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle)
- Applicant
- Djo Global
- Product code
- NTG
- Decision date
- 2022-05-06
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Approval order statement
- Approval of the post approval study protocol referenced in the Actual Condition of Use Study (STAR 2).
Current openFDA PMA Record#
- Device
- Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle)
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S021
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2022-05-06
- Decision code
- APPR
- Date received
- 2022-01-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the post approval study protocol referenced in the Actual Condition of Use Study (STAR 2).