PMA P050050S018

Device: Scandinavian Total Ankle Replacement (STAR Ankle)
Applicant: Djo Global
PMA number: P050050
Supplement: S018
Product code: NTG
Decision date: 2021-04-19
Generic name: Prosthesis, ankle, uncemented, non-constrained
Approval order statement: Due to the breakage of the original grinding machine, the old grinding machine is no longer able to function and therefore needs to be replaced.

Current openFDA PMA Record#

Device: Scandinavian Total Ankle Replacement (STAR Ankle)
Applicant: Djo Global
PMA number: P050050
Supplement: S018
Product code: NTG
Generic name: Prosthesis, ankle, uncemented, non-constrained
Decision date: 2021-04-19
Decision code: OK30
Date received: 2021-03-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Due to the breakage of the original grinding machine, the old grinding machine is no longer able to function and therefore needs to be replaced.