The following data is part of a premarket notification filed by Xenco Medical, Llc with the FDA for Xenco Medical Cervical Interbody System.
| Device ID | K140786 |
| 510k Number | K140786 |
| Device Name: | XENCO MEDICAL CERVICAL INTERBODY SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | XENCO MEDICAL, LLC 9930 MESA RIM DRIVE San Diego, CA 92121 |
| Contact | Gustavo R Prado |
| Correspondent | Gustavo R Prado XENCO MEDICAL, LLC 9930 MESA RIM DRIVE San Diego, CA 92121 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-31 |
| Decision Date | 2014-09-03 |