PMA P050050S001
- Device
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S001
- Product code
- NTG
- Decision date
- 2010-10-08
- Classification
- Prosthesis, Ankle, Uncemented, Non-constrained
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S001
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2010-10-08
- Decision code
- APPR
- Date received
- 2009-08-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.