The following data is part of a premarket notification filed by Genesys Spine with the FDA for Tilock2 Spinal System.
| Device ID | K171838 |
| 510k Number | K171838 |
| Device Name: | TiLock2 Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Genesys Spine 1250 Capital Of Texas Highway South Building 3, Suite 600 Austin, TX 78746 |
| Contact | William W. Sowers |
| Correspondent | William W. Sowers Genesys Spine 1250 Capital Of Texas Highway South Building Three, Suite 600 Austin, TX 78746 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-20 |
| Decision Date | 2017-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M719GLC47620 | K171838 | 000 |
| M719GL3220 | K171838 | 000 |
| M719GL3270 | K171838 | 000 |
| M719GLC4840 | K171838 | 000 |
| M719GLC125S0 | K171838 | 000 |
| M719GLC429S0 | K171838 | 000 |
| M719GLC4670 | K171838 | 000 |
| M719GLC4810 | K171838 | 000 |
| M719GLC48210 | K171838 | 000 |
| M719GLC48220 | K171838 | 000 |
| M719G88510 | K171838 | 000 |
| M719GL4240 | K171838 | 000 |
| M719GLC2120 | K171838 | 000 |
| M719GLC46810 | K171838 | 000 |
| M719GLC46820 | K171838 | 000 |
| M719GLC47210 | K171838 | 000 |
| M719GLC47220 | K171838 | 000 |
| M719GLC47610 | K171838 | 000 |
| M719GLC7000 | K171838 | 000 |