PMA
P050050: SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
FDA PMA · Prosthesis, ankle, uncemented, non-constrained · Djo Global
Key facts
| PMA number | P050050 |
|---|---|
| Trade name | SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) |
| Generic name | Prosthesis, ankle, uncemented, non-constrained |
| Applicant | Djo Global |
| Owner/operator | ENCORE MEDICAL, L.P. |
| Product code | NTG |
| Approval date | May 27, 2009 |
| Docket number | 11M-0323 |
| Notice date | May 10, 2011 |
| Establishment registration | 1644408 |
| FEI number | 1000116912 |
At a glance
- 10–99 Supplements
- Mar 13, 2024 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: