Bright Spine · Class II · Cleared Jan 13, 2023
| K-number | K221542 |
| Device name | Galileo Vertebral Body Replacement Device |
| Applicant | Bright Spine |
| Product code | PLR |
| Device class | Class II |
| Decision date | Jan 13, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 888.3060 |
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