The following data is part of a premarket notification filed by Paragon 28 with the FDA for Breakaway Screw System.
| Device ID | K172886 |
| 510k Number | K172886 |
| Device Name: | Breakaway Screw System |
| Classification | Plate, Fixation, Bone |
| Applicant | Paragon 28 4B Inverness Ct. E Ste 280 Englewood, CO 80112 |
| Contact | Eric Lintula |
| Correspondent | Eric Lintula Paragon 28 4B Inverness Ct. E Ste 280 Englewood, CO 80112 |
| Product Code | HRS |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-21 |
| Decision Date | 2017-12-20 |
| Summary: | summary |