The following data is part of a premarket notification filed by Xenco Medical, Llc with the FDA for Xenco Medical Posterior Cervical System.
| Device ID | K161478 |
| 510k Number | K161478 |
| Device Name: | Xenco Medical Posterior Cervical System |
| Classification | Posterior Cervical Screw System |
| Applicant | Xenco Medical, LLC 9930 Mesa Rim Road San Diego, CA 92121 |
| Contact | Gustavo Prado |
| Correspondent | Gustavo Prado, Ph.d. Xenco Medical, LLC 9930 Mesa Rim Road San Diego, CA 92121 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-31 |
| Decision Date | 2016-09-06 |