The following data is part of a premarket notification filed by Astura Medical with the FDA for El Capitan Anterior Lumbar Interbody Fusion System.
| Device ID | K214047 |
| 510k Number | K214047 |
| Device Name: | EL CAPITAN Anterior Lumbar Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Astura Medical 4949 W Royal Ln. Irving, TX 75063 |
| Contact | Parker Kelch |
| Correspondent | Parker Kelch Astura Medical 4949 W Royal Ln. Irving, TX 75063 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-03-30 |