The following data is part of a premarket notification filed by Bionx Implants, Ltd. with the FDA for Thermofx Mesh.
| Device ID | K003757 |
| 510k Number | K003757 |
| Device Name: | THERMOFX MESH |
| Classification | Plate, Bone |
| Applicant | BIONX IMPLANTS, LTD. HERMIANKATU 6-8 L Tampere, FI Fin-33720 |
| Contact | Tuija Annala |
| Correspondent | Tuija Annala BIONX IMPLANTS, LTD. HERMIANKATU 6-8 L Tampere, FI Fin-33720 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-06 |
| Decision Date | 2001-02-07 |