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 | K191782 |
| 510k Number | K191782 |
| Device Name: | TTC Phantom Intramedullary Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Paragon 28, Inc. 4B Inverness Ct. E., STE 280 Englewood, CO 80112 |
| Contact | Eric Lintula |
| Correspondent | Eric Lintula Paragon 28, Inc. 4B Inverness Ct. E., STE 280 Englewood, CO 80112 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-02 |
| Decision Date | 2019-09-06 |
| Summary: | summary |