The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for X-spine Cortical Bone Screw System.
| Device ID | K180153 |
| 510k Number | K180153 |
| Device Name: | X-spine Cortical Bone Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | X-spine Systems, Inc. 664 Cruiser Lane Belgrade, MT 59714 |
| Contact | Charlene Brumbaugh |
| Correspondent | Charlene Brumbaugh X-spine Systems, Inc. 664 Cruiser Lane Belgrade, MT 59714 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-19 |
| Decision Date | 2018-03-15 |
| Summary: | summary |