The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Tilock System.
| Device ID | K103671 |
| 510k Number | K103671 |
| Device Name: | GENESYS SPINE TILOCK SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 Austin, TX 78746 |
| Contact | Brian J Bergeron |
| Correspondent | Brian J Bergeron 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-16 |
| Decision Date | 2011-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7197406215M0 | K103671 | 000 |
| M719G88010 | K103671 | 000 |
| M719G88020 | K103671 | 000 |
| M719G88100 | K103671 | 000 |
| M719G88110 | K103671 | 000 |
| M719G88120 | K103671 | 000 |
| M719G88130 | K103671 | 000 |
| M719G88140 | K103671 | 000 |
| M719G88150 | K103671 | 000 |
| M719G88160 | K103671 | 000 |
| M719G88170 | K103671 | 000 |
| M719G88180 | K103671 | 000 |
| M719G88190 | K103671 | 000 |
| M719G99980 | K103671 | 000 |
| M719G99990 | K103671 | 000 |
| M719GL201F0 | K103671 | 000 |
| M719G87030 | K103671 | 000 |
| M719G87020 | K103671 | 000 |
| M7197417401M0 | K103671 | 000 |
| M7197424901M0 | K103671 | 000 |
| M719G6000C0 | K103671 | 000 |
| M719G6001C0 | K103671 | 000 |
| M719G60040 | K103671 | 000 |
| M719G70075450 | K103671 | 000 |
| M719G70165650 | K103671 | 000 |
| M719G70175650 | K103671 | 000 |
| M719G70180 | K103671 | 000 |
| M719G71165650 | K103671 | 000 |
| M719G71175650 | K103671 | 000 |
| M719G8500C0 | K103671 | 000 |
| M719G8501C0 | K103671 | 000 |
| M719G87000 | K103671 | 000 |
| M719G87010 | K103671 | 000 |
| M719GLC4800 | K103671 | 000 |
| M719GLC4850 | K103671 | 000 |
| M719GLC48510 | K103671 | 000 |
| M719GM13410 | K103671 | 000 |
| M719GM13420 | K103671 | 000 |
| M719GM1370 | K103671 | 000 |
| M719GM138MS0 | K103671 | 000 |
| M719GM138SC0 | K103671 | 000 |
| M719GM139MS0 | K103671 | 000 |
| M719GM139SC0 | K103671 | 000 |
| M719GM5510 | K103671 | 000 |
| M719GM5610 | K103671 | 000 |
| M719GM5811300 | K103671 | 000 |
| M719GSN1480 | K103671 | 000 |
| M719GSN1550 | K103671 | 000 |
| M719GSN1650 | K103671 | 000 |
| M719GSN1750 | K103671 | 000 |
| M719GL101RL0 | K103671 | 000 |
| M719GM1270 | K103671 | 000 |
| M719GM126C600 | K103671 | 000 |
| M719GLC48810 | K103671 | 000 |
| M719GLC48820 | K103671 | 000 |
| M719GLC489L0 | K103671 | 000 |
| M719GLC4910600 | K103671 | 000 |
| M719GLC4920 | K103671 | 000 |
| M719GLC4930 | K103671 | 000 |
| M719GLC49470 | K103671 | 000 |
| M719GLC5030 | K103671 | 000 |
| M719GM105R0 | K103671 | 000 |
| M719GM1070 | K103671 | 000 |
| M719GM109L0 | K103671 | 000 |
| M719GM119L0 | K103671 | 000 |
| M719GM1210 | K103671 | 000 |
| M719GM126C480 | K103671 | 000 |
| M719GM126C550 | K103671 | 000 |
| M719GL102RL0 | K103671 | 000 |