The following data is part of a premarket notification filed by Xenco Medical, Llc with the FDA for Cancellex Porous Titanium Lumbar Interbody Device.
| Device ID | K190364 |
| 510k Number | K190364 |
| Device Name: | CancelleX Porous Titanium Lumbar Interbody Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Xenco Medical, LLC 9930 Mesa Rim Road San Diego, CA 92121 |
| Contact | Jason Haider |
| Correspondent | Korina A. Akhondzadeh KARA & Associates 6965 El Camino Real Suite 105-428 Carlsbad, CA 92009 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-15 |
| Decision Date | 2019-04-18 |