The following data is part of a premarket notification filed by Xenco Medical, Llc with the FDA for Xenco Medical Lumbar Interbody System.
| Device ID | K143158 |
| 510k Number | K143158 |
| Device Name: | Xenco Medical Lumbar Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Xenco Medical, LLC 9930 Mesa Rim Road San Diego, CA 92121 |
| Contact | Gustavo Prado |
| Correspondent | Gustavo Prado Xenco Medical, LLC 9930 Mesa Rim Road San Diego, CA 92121 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2015-03-20 |