| K-number | K141345 |
| Device name | AEQUALIS FX2 |
| Applicant | Tornier S.A.S. |
| Product code | PHX |
| Device class | Class II |
| Decision date | Nov 18, 2014 |
| Decision | Substantially Equivalent |
| Regulation | 888.3660 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov