The following data is part of a premarket notification filed by Benvenue Medical, Inc. with the FDA for Luna Xd Ti Interbody Fusion System.
| Device ID | K193172 |
| 510k Number | K193172 |
| Device Name: | Luna XD Ti Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Benvenue Medical, Inc. 4590 Patrick Henry Dr. Santa Clara, CA 95054 |
| Contact | Laurent Schaller |
| Correspondent | Justin Eggleton MCRA, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-15 |
| Decision Date | 2020-07-02 |