PMA P050050

Device: Scandinavian Total Ankle Replacement (STAR)
Applicant: Djo Global
PMA number: P050050
Supplement: S025
Product code: NTG
Decision date: 2024-03-13
Generic name: Prosthesis, ankle, uncemented, non-constrained
Approval order statement: The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P050050/S024 (Scandinavian Total Ankle Replacement System).

Current openFDA PMA Record#

Device: Scandinavian Total Ankle Replacement (STAR)
Applicant: Djo Global
PMA number: P050050
Supplement: S026
Product code: NTG
Generic name: Prosthesis, ankle, uncemented, non-constrained
Decision date: 2024-03-13
Decision code: APPR
Date received: 2023-12-13
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P050050/S024 (Scandinavian Total Ankle Replacement System).