PMA P050050S025

Device: Scandinavian Total Ankle Replacement (STAR Ankle)
Applicant: Djo Global
PMA number: P050050
Supplement: S025
Product code: NTG
Decision date: 2022-09-29
Generic name: Prosthesis, ankle, uncemented, non-constrained
Approval order statement: Replacing a milling machine with three newer machines. The milling machine is used in the manufacturing of the STAR Ankle polyethylene bearing components.

Current openFDA PMA Record#

Device: Scandinavian Total Ankle Replacement (STAR Ankle)
Applicant: Djo Global
PMA number: P050050
Supplement: S025
Product code: NTG
Generic name: Prosthesis, ankle, uncemented, non-constrained
Decision date: 2022-09-29
Decision code: OK30
Date received: 2022-09-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacing a milling machine with three newer machines. The milling machine is used in the manufacturing of the STAR Ankle polyethylene bearing components.