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 |