The following data is part of a premarket notification filed by Organogenesis, Inc. with the FDA for Fortaflex Surgical Mesh.
| Device ID | K011025 |
| 510k Number | K011025 |
| Device Name: | FORTAFLEX SURGICAL MESH |
| Classification | Mesh, Surgical |
| Applicant | ORGANOGENESIS, INC. 150 DAN RD. Canton, MA 02021 |
| Contact | Patrick R Bilbo |
| Correspondent | Patrick R Bilbo ORGANOGENESIS, INC. 150 DAN RD. Canton, MA 02021 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-05 |
| Decision Date | 2001-08-24 |