The following data is part of a premarket notification filed by Paragon 28, Inc. with the FDA for Baby Gorilla/gorilla Plating System.
| Device ID | K221465 |
| 510k Number | K221465 |
| Device Name: | Baby Gorilla/Gorilla Plating System |
| Classification | Plate, 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 | 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 | 2022-05-19 |
| Decision Date | 2022-06-17 |