The following data is part of a premarket notification filed by Astura Medical, Llc with the FDA for Sirion Lateral Lumbar Interbody System.
| Device ID | K192006 |
| 510k Number | K192006 |
| Device Name: | SIRION Lateral Lumbar Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Astura Medical, LLC 3168 Lionshead Ave, Suite 100 Carlsbad, CA 92010 |
| Contact | Parker Kelch |
| Correspondent | Parker Kelch Astura Medical, LLC 3168 Lionshead Ave, Suite 100 Carlsbad, CA 92010 |
| Product Code | MAX |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2020-04-02 |