The following data is part of a premarket notification filed by Benvenue Medical, Inc. with the FDA for Luna 3d Interbody Fusion System.
| Device ID | K162431 |
| 510k Number | K162431 |
| Device Name: | Luna 3D Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Benvenue Medical, Inc. 5403 Betsy Ross Drive Santa Clara, CA 95054 |
| Contact | Jeff Emery |
| Correspondent | Justin Eggleton MCRA, LLC 1331 H Street NW, 12th Floor Washington, DC 20005 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-31 |
| Decision Date | 2016-11-17 |
| Summary: | summary |