The following data is part of a premarket notification filed by Pantheon Spinal with the FDA for Pantheon Ibfd.
| Device ID | K203003 |
| 510k Number | K203003 |
| Device Name: | Pantheon IBFD |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Pantheon Spinal 40132 Industrial Park Circle Suite 101 Georgetown, TX 78626 |
| Contact | Dave Lamb |
| Correspondent | Dave Lamb Pantheon Spinal 40132 Industrial Park Circle Suite 101 Georgetown, TX 78626 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-01 |
| Decision Date | 2021-07-07 |