PMA P050050S020

Device
Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)
Applicant
Djo Global
PMA number
P050050
Supplement
S020
Product code
NTG
Decision date
2021-12-17
Generic name
Prosthesis, ankle, uncemented, non-constrained
Approval order statement
Approval for addition of a symbol to the package labels of STAR stainless steel instruments.

Current openFDA PMA Record#

Device
Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)
Applicant
Djo Global
PMA number
P050050
Supplement
S020
Product code
NTG
Generic name
Prosthesis, ankle, uncemented, non-constrained
Decision date
2021-12-17
Decision code
APPR
Date received
2021-11-19
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for addition of a symbol to the package labels of STAR stainless steel instruments.