FDA.reportPublic FDA data

PMA P050050S016

Device
Scandinavian Total Ankle Replacment (STAR Ankle)
Applicant
Djo Global
PMA number
P050050
Supplement
S016
Product code
NTG
Decision date
2021-01-13
Generic name
Prosthesis, ankle, uncemented, non-constrained
Approval order statement
Replace a broken coordinate measuring machine (CMM) used in the production of the STAR Tibial, Talar, and UHMWPE Mobile Bearing (also referred to as the Sliding Cores) components with another CMM (Zeiss Contura CMM) at the Waldemar Link contract manufacturing facility in Germany.

Current openFDA PMA Record#

Device
Scandinavian Total Ankle Replacment (STAR Ankle)
Applicant
Djo Global
PMA number
P050050
Supplement
S016
Product code
NTG
Generic name
Prosthesis, ankle, uncemented, non-constrained
Decision date
2021-01-13
Decision code
OK30
Date received
2020-12-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replace a broken coordinate measuring machine (CMM) used in the production of the STAR Tibial, Talar, and UHMWPE Mobile Bearing (also referred to as the Sliding Cores) components with another CMM (Zeiss Contura CMM) at the Waldemar Link contract manufacturing facility in Germany.