The following data is part of a premarket notification filed by Bright Spine, Inc with the FDA for Bright Spine Galileo Spinal Spacer System.
| Device ID | K102449 |
| 510k Number | K102449 |
| Device Name: | BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | BRIGHT SPINE, INC 799 N.E. 71ST STREET Boca Raton, FL 33487 |
| Contact | Robert Simonson |
| Correspondent | Robert Simonson BRIGHT SPINE, INC 799 N.E. 71ST STREET Boca Raton, FL 33487 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-27 |
| Decision Date | 2011-02-11 |
| Summary: | summary |