| K-number | K003757 |
| Device name | THERMOFX MESH |
| Applicant | Bionx Implants, Ltd. |
| Product code | JEY |
| Device class | Class II |
| Decision date | Feb 7, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 872.4760 |
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