The following data is part of a premarket notification filed by Paragon 28, Inc. with the FDA for Ttc Phantom® Intramedullary Nail System.
| Device ID | K192163 |
| 510k Number | K192163 |
| Device Name: | TTC Phantom® Intramedullary Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112 |
| Contact | Haylie Hertz |
| Correspondent | Haylie Hertz Paragon 28, Inc. 1445 Grasslands Dr. Englewood, CO 80112 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2020-01-31 |
| Summary: | summary |