The following data is part of a premarket notification filed by Paragon 28, Inc. with the FDA for Hammertoe Compression System.
| Device ID | K183228 |
| 510k Number | K183228 |
| Device Name: | HammerToe Compression System |
| Classification | Pin, Fixation, Smooth |
| 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 | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-20 |
| Decision Date | 2019-01-25 |
| Summary: | summary |