The following data is part of a premarket notification filed by Paragon 28, Inc. with the FDA for R3act Stabilization System.
| Device ID | K211770 |
| 510k Number | K211770 |
| Device Name: | R3ACT Stabilization System |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-08 |
| Decision Date | 2021-12-25 |