PMA P050050S008
- Device
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S008
- Product code
- NTG
- Decision date
- 2016-09-01
- Classification
- Prosthesis, Ankle, Uncemented, Non-constrained
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Approval order statement
- Approval of changes to the post-approval study protocol.
Current openFDA PMA Record#
- Device
- SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
- Applicant
- Djo Global
- PMA number
- P050050
- Supplement
- S008
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2016-09-01
- Decision code
- APPR
- Date received
- 2016-04-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of changes to the post-approval study protocol.