The following data is part of a premarket notification filed by Xenco Medical, Llc with the FDA for Setx Pedicle Screw System.
| Device ID | K170611 |
| 510k Number | K170611 |
| Device Name: | SETx Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Xenco Medical, LLC 9930 Mesa Rim Road San Diego, CA 92121 |
| Contact | Gustavo Prado |
| Correspondent | Gustavo Prado Xenco Medical, LLC 9930 Mesa Rim Road San Diego, CA 92121 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-01 |
| Decision Date | 2017-05-25 |