The following data is part of a premarket notification filed by Paragon 28, Inc with the FDA for Small Bone Phantom® Intramedullary Nail System; Ttc Phantom® Intramedullary Nail System.
| Device ID | K182307 |
| 510k Number | K182307 |
| Device Name: | Small Bone Phantom® Intramedullary Nail System; 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 |
| Subsequent Product Code | HWC |
| Subsequent Product Code | KTW |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-24 |
| Decision Date | 2019-01-14 |
| Summary: | summary |