| K-number | K230974 |
| Device name | NIDO Pedicle Screw System |
| Applicant | Kalitec Medical |
| Product code | NKB |
| Device class | Class II |
| Decision date | Sep 15, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 888.3070 |
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