The following data is part of a premarket notification filed by Bright Spine with the FDA for Galileo Vertebral Body Replacement Device.
| Device ID | K192145 |
| 510k Number | K192145 |
| Device Name: | Galileo Vertebral Body Replacement Device |
| Classification | Spinal Vertebral Body Replacement Device - Cervical |
| Applicant | Bright Spine 799 NE 71st Street Boca Raton, FL 33487 |
| Contact | Robert Simonson |
| Correspondent | Bahram Parvinian Lighthouse Regulatory Consulting Group 3 Harrowgate CT Potomac, MD 20854 |
| Product Code | PLR |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-08 |
| Decision Date | 2020-04-21 |