The following data is part of a premarket notification filed by Astura Medical, Llc with the FDA for Sirion Lateral Lumbar Interbody Fusion.
| Device ID | K202495 |
| 510k Number | K202495 |
| Device Name: | SIRION Lateral Lumbar Interbody Fusion |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Astura Medical, LLC 4949 W Royal Ln Irving, TX 75063 |
| Contact | Parker Kelch |
| Correspondent | Parker Kelch Astura Medical, LLC 4949 W Royal Ln Irving, TX 75063 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-31 |
| Decision Date | 2021-01-06 |