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 | K210590 |
| 510k Number | K210590 |
| 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 | 2021-03-01 |
| Decision Date | 2021-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056619802899 | K210590 | 000 |
| 05056619802882 | K210590 | 000 |
| 05056619802875 | K210590 | 000 |
| 05056619802868 | K210590 | 000 |
| 05056619802851 | K210590 | 000 |
| 05056619802844 | K210590 | 000 |
| 05056619802837 | K210590 | 000 |
| 05056619802820 | K210590 | 000 |
| 05056619802813 | K210590 | 000 |