The following data is part of a premarket notification filed by Spinal Usa with the FDA for Spinal Usa Vbr System.
| Device ID | K081196 |
| 510k Number | K081196 |
| Device Name: | SPINAL USA VBR SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINAL USA 644 LAKELAND EAST DR., STE. A Flowood, MS 39232 |
| Contact | Jeffrey Johnson |
| Correspondent | Jeffrey Johnson SPINAL USA 644 LAKELAND EAST DR., STE. A Flowood, MS 39232 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-28 |
| Decision Date | 2008-10-16 |
| Summary: | summary |