The following data is part of a premarket notification filed by Benvenue Medical, Inc. with the FDA for Luna Interbody System.
| Device ID | K142023 |
| 510k Number | K142023 |
| Device Name: | LUNA INTERBODY SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | BENVENUE MEDICAL, INC. 1171 BARROILHET DR. Hillsborough, CA 94010 |
| Contact | Cindy Domecus, R.a.c. (us & Eu) |
| Correspondent | Cindy Domecus, R.a.c. (us & Eu) BENVENUE MEDICAL, INC. 1171 BARROILHET DR. Hillsborough, CA 94010 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-25 |
| Decision Date | 2014-11-20 |
| Summary: | summary |