The following data is part of a premarket notification filed by Genesys Spine with the FDA for Tilock Modular Spinal System.
| Device ID | K172469 |
| 510k Number | K172469 |
| Device Name: | TiLock Modular 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 | Brian J. Bergeron |
| Correspondent | Brian J. Bergeron Genesys Spine 1250 Capital Of Texas Highway South Building 3 Suite 600 Austin, TX 78746 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-15 |
| Decision Date | 2017-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M719GL304850 | K172469 | 000 |
| M719GMCS60450 | K172469 | 000 |
| M719GMCS60400 | K172469 | 000 |
| M719GMCS60350 | K172469 | 000 |
| M719GMCS60300 | K172469 | 000 |
| M719GMCS60250 | K172469 | 000 |
| M719GMCS55550 | K172469 | 000 |
| M719GMCD60600 | K172469 | 000 |
| M719GMCD60550 | K172469 | 000 |
| M719GMCD60500 | K172469 | 000 |
| M719GMCD60450 | K172469 | 000 |
| M719GMCD60400 | K172469 | 000 |
| M719GMCD60350 | K172469 | 000 |
| M719GMCD60300 | K172469 | 000 |
| M719GMCS60500 | K172469 | 000 |
| M719GMCS60550 | K172469 | 000 |
| M719GM8210 | K172469 | 000 |
| M719GM135SN0 | K172469 | 000 |
| M719GM135MS0 | K172469 | 000 |
| M719GM1350 | K172469 | 000 |
| M719GMSS60600 | K172469 | 000 |
| M719GMSS60550 | K172469 | 000 |
| M719GMSS60500 | K172469 | 000 |
| M719GMSS60450 | K172469 | 000 |
| M719GMSS60400 | K172469 | 000 |
| M719GMSS60350 | K172469 | 000 |
| M719GMSS60300 | K172469 | 000 |
| M719GMSS60250 | K172469 | 000 |
| M719GMCS60600 | K172469 | 000 |
| M719GMCD60250 | K172469 | 000 |