The following data is part of a premarket notification filed by Paragon 28, Inc with the FDA for Paragon 28 External Ring Fixation System.
| Device ID | K212895 |
| 510k Number | K212895 |
| Device Name: | Paragon 28 External Ring Fixation System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Paragon 28, Inc 14445 Grasslands Dr. Englewood, CO 80112 |
| Contact | Haylie Hertz |
| Correspondent | Haylie Hertz Paragon 28, Inc 14445 Grasslands Dr. Englewood, CO 80112 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-10 |
| Decision Date | 2021-11-08 |