Paragon 28, Inc. · Class II · Cleared Aug 19, 2022
| K-number | K222194 |
| Device name | Baby Gorilla®/Gorilla® Plating System |
| Applicant | Paragon 28, Inc. |
| Product code | HRS |
| Device class | Class II |
| Decision date | Aug 19, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov