Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K230446
TiLink-L SI Joint Fusion System · SurGenTec, LLC · decided 2023-06-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| TiLink-L Screw Drill Bit - 8mm 3D Printed | SR21-6205 | Surgentec, LLC | OUR | 00810131880507 |
| Lateral Drill Guide | SR21-6001 | Surgentec, LLC | OUR | 00850040139891 |
| Lateral SI Screw Inserter Torque Driver | SR21-6004 | Surgentec, LLC | OUR | 00850040139921 |
| Lateral Graft Tamp | SR21-6006 | Surgentec, LLC | OUR | 00850040139945 |
| Lateral Impact Cap | SR21-6003 | Surgentec, LLC | OUR | 00850040139914 |
| "TiLink-L Reamer - 3/16"" Square Connection" | SR21-6011 | Surgentec, LLC | OUR | 00810131880651 |
| TiLink-L Bone Graft Funnel | SR21-6200 | Surgentec, LLC | OUR | 00810131880378 |
| TiLink-L Implant Caddy | SR21-7001 | Surgentec, LLC | OUR | 00810131880248 |
| TiLink-L Bone Graft Pusher Assembly | SR21-2201 | Surgentec, LLC | OUR | 00810131880385 |
| SI-Lateral Ratcheting T-Handle | SR21-5002 | Surgentec, LLC | OUR | 00810131880026 |
| TiLink-L Reamer | SR21-6008 | Surgentec, LLC | OUR | 00810131880316 |
| TiLink-L Transfer Pin | SR21-5003 | Surgentec, LLC | OUR | 00810131880071 |
| "TiLink-L Screw Drill Bit - 8mm - 3/16"" Square Connection" | SR21-6010 | Surgentec, LLC | OUR | 00810131880644 |
| " Guidewire - 12""" | SR21-5001 | Surgentec, LLC | OUR | 00850040139877 |
| " Guidewire - 15.5""" | SR21-5004 | Surgentec, LLC | OUR | 00810131880415 |
| TiLink-L Sterilization Tray | SR21-7004 | Surgentec, LLC | OUR | 00810131880255 |
| Lateral Dilator | SR21-6000 | Surgentec, LLC | OUR | 00850040139884 |
| Lateral Removal Tool | SR21-6007 | Surgentec, LLC | OUR | 00850040139952 |
| "TiLink-L Screw Inserter Hexalobe Driver - 3/16"" Square Connection" | SR21-6009 | Surgentec, LLC | OUR | 00810131880637 |