The following data is part of a premarket notification filed by Astura Medical, Llc with the FDA for Half Dome Posterior Lumbar Interbody System.
| Device ID | K182877 |
| 510k Number | K182877 |
| Device Name: | HALF DOME Posterior Lumbar Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Astura Medical, LLC 3186 Lionshead Ave, Suite 100 Carlsbad, CA 92010 |
| Contact | Parker Kelch |
| Correspondent | Parker Kelch Astura Medical, LLC 3186 Lionshead Ave, Suite 100 Carlsbad, CA 92010 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-15 |
| Decision Date | 2019-05-03 |