The following data is part of a premarket notification filed by Pantheon Spinal with the FDA for Pantheon Spinal Pontus Interbody Fusion Device.
| Device ID | K181548 |
| 510k Number | K181548 |
| Device Name: | Pantheon Spinal Pontus Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Pantheon Spinal 3008 Bee Cave Road, Suite 200 Austin, TX 78746 |
| Contact | Bob Schultz |
| Correspondent | Dave Lamb Pantheon Spinal 3008 Bee Cave Road, Suite 200 Austin, TX 78746 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-12 |
| Decision Date | 2019-12-16 |