The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Spinefrontier Dorado Vbr.
| Device ID | K072289 |
| 510k Number | K072289 |
| Device Name: | SPINEFRONTIER DORADO VBR |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINEFRONTIER, INC. 100 CUMMINGS CENTER SUITE 240C Beverly, MA 01915 |
| Contact | Tom Carlson |
| Correspondent | Tom Carlson SPINEFRONTIER, INC. 100 CUMMINGS CENTER SUITE 240C Beverly, MA 01915 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-16 |
| Decision Date | 2007-11-01 |
| Summary: | summary |