The following data is part of a premarket notification filed by Genesys Spine with the FDA for Tilock Pedicle Screw System.
| Device ID | K100757 |
| 510k Number | K100757 |
| Device Name: | TILOCK PEDICLE SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 Austin, TX 78746 |
| Contact | Josh Kaufmann |
| Correspondent | Josh Kaufmann GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-17 |
| Decision Date | 2010-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M719G1501050 | K100757 | 000 |
| M719GL3130 | K100757 | 000 |
| M719GL3120 | K100757 | 000 |
| M719GL3100 | K100757 | 000 |
| M719GL2240 | K100757 | 000 |
| M719GL2220 | K100757 | 000 |
| M719GL217NC0 | K100757 | 000 |
| M719GL212NC0 | K100757 | 000 |
| M719GL201TIB0 | K100757 | 000 |
| M719G00020 | K100757 | 000 |
| M719G00010 | K100757 | 000 |
| M719G00000 | K100757 | 000 |
| M71930051400 | K100757 | 000 |
| M719GL3150 | K100757 | 000 |
| M719GL4210 | K100757 | 000 |
| M719GLC409850 | K100757 | 000 |
| M719GLC4780 | K100757 | 000 |
| M719GLC4660 | K100757 | 000 |
| M719GLC4630 | K100757 | 000 |
| M719GLC4620 | K100757 | 000 |
| M719GLC46110 | K100757 | 000 |
| M719GLC4600 | K100757 | 000 |
| M719GLC4590 | K100757 | 000 |
| M719GLC453R0 | K100757 | 000 |
| M719GLC453L0 | K100757 | 000 |
| M719GLC452R0 | K100757 | 000 |
| M719GLC452L0 | K100757 | 000 |
| M719GLC42510 | K100757 | 000 |
| M71930051300 | K100757 | 000 |