PMA P050050S011

Device
S.T.A.R. Ankle System
Applicant
Djo Global
PMA number
P050050
Supplement
S011
Product code
NTG
Decision date
2018-01-08
Classification
Prosthesis, Ankle, Uncemented, Non-constrained
Generic name
Prosthesis, ankle, uncemented, non-constrained
Approval order statement
Approval for new labeling materials.

Current openFDA PMA Record#

Device
S.T.A.R. Ankle System
Applicant
Djo Global
PMA number
P050050
Supplement
S011
Product code
NTG
Generic name
Prosthesis, ankle, uncemented, non-constrained
Decision date
2018-01-08
Decision code
APPR
Date received
2017-10-10
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for new labeling materials.