Orthofundamentals, LLC · Class II · Cleared Apr 11, 2022
| K-number | K212962 |
| Device name | TRELLIS SI Joint Fusion System |
| Applicant | Orthofundamentals, LLC |
| Product code | OUR |
| Device class | Class II |
| Decision date | Apr 11, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
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