The following data is part of a premarket notification filed by Axis Spine Technologies Ltd with the FDA for Axis Spine Technologies Alif.
| Device ID | K200352 |
| 510k Number | K200352 |
| Device Name: | Axis Spine Technologies ALIF |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Axis Spine Technologies Ltd Suite 204, 54-56 Victoria Street, St. Albans, GB Al1 3hz |
| Contact | Edwin Lindsay |
| Correspondent | Edwin Lindsay Axis Spine Technologies Ltd Suite 204, 54-56 Victoria Street, St. Albans, GB Al1 3hz |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-13 |
| Decision Date | 2020-05-20 |