The following data is part of a premarket notification filed by Aegis Spine, Inc. with the FDA for Abtross Alif Expandable Cage System.
| Device ID | K221719 |
| 510k Number | K221719 |
| Device Name: | ABTross ALIF Expandable Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Aegis Spine, Inc. 9781 S. Meridian Blvd, Ste 300 Englewood, CO 80112 |
| Contact | KiHyang Kim |
| Correspondent | KiHyang Kim Aegis Spine, Inc. 9781 S. Meridian Blvd, Ste 300 Englewood, CO 80112 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-13 |
| Decision Date | 2022-11-03 |