The following data is part of a premarket notification filed by Paragon 28, Inc with the FDA for Tenotac Soft Tissue Fixation System.
| Device ID | K203385 |
| 510k Number | K203385 |
| Device Name: | TenoTac Soft Tissue Fixation System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Paragon 28, Inc 14445 Grasslands Dr. Englewood, CO 80112 |
| Contact | Haylie Hertz |
| Correspondent | Haylie Hertz Paragon 28, Inc 14445 Grasslands Dr. Englewood, CO 80112 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-18 |
| Decision Date | 2021-02-11 |