The following data is part of a premarket notification filed by Xenco Medical, Llc with the FDA for Xenco Medical Pedicle Screw System.
| Device ID | K160986 |
| 510k Number | K160986 |
| Device Name: | Xenco Medical Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | XENCO MEDICAL, LLC 9930 MESA RIM DRIVE San Diego, CA 92121 |
| Contact | Gustavo Prado |
| Correspondent | Gustavo Prado XENCO MEDICAL, LLC 9930 MESA RIM ROAD San Diego, CA 92121 |
| Product Code | NKB |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-08 |
| Decision Date | 2016-05-04 |