PMA P050050S004
- Device
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S004
- Product code
- NTG
- Decision date
- 2013-05-01
- Classification
- Prosthesis, Ankle, Uncemented, Non-constrained
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ZRINSKI AG IN WURMLINGEN, GERMANY.
Current openFDA PMA Record#
- Device
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S004
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2013-05-01
- Decision code
- APPR
- Date received
- 2012-09-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ZRINSKI AG IN WURMLINGEN, GERMANY.