The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Tilock Cortical Spinal System.
| Device ID | K161914 |
| 510k Number | K161914 |
| Device Name: | Genesys Spine TiLock Cortical Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Genesys Spine 1250 Capital Of Texas Of Highway South, Building 3 Suite 600 Austin, TX 78746 |
| Contact | William W. Sowers |
| Correspondent | William W. Sowers Genesys Spine 1250 Capital Of Texas Of Highway South, Building Three, Suite 600 Austin, TX 78746 |
| Product Code | NKB |
| 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 | 2016-07-12 |
| Decision Date | 2016-08-09 |
| Summary: | summary |