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 | K180373 |
| 510k Number | K180373 |
| 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 | Gustavo R. Prado |
| Correspondent | Gustavo R. 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 | 2018-02-12 |
| Decision Date | 2018-08-24 |
| Summary: | summary |