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 | K151733 |
| 510k Number | K151733 |
| Device Name: | Xenco Medical 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 R. 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-26 |
| Decision Date | 2015-09-04 |