| Primary Device ID | 00810055524617 |
| NIH Device Record Key | 5357cb24-e43e-4821-b787-6abf42c6a85d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iFuse INTRA X Instrument Set |
| Version Model Number | 400471 |
| Company DUNS | 830127168 |
| Company Name | Si-Bone Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00810055524723 - iFuse TORQ TNT Implant System Instrument Tray – 16 mm Washer Caddy | 2024-11-21 iFuse TORQ TNT Implant System Instrument Tray – 16 mm Washer Caddy |
| 00810055524730 - iFuse TORQ TNT Implant System Instrument Tray – 21 mm Washer Caddy | 2024-11-21 iFuse TORQ TNT Implant System Instrument Tray – 21 mm Washer Caddy |
| 00810055524709 - iFuse TORQ TNT Instrument Tray | 2024-10-03 iFuse TORQ TNT Instrument Tray |
| 00810055524716 - iFuse TORQ TNT Navigation Instrument Tray | 2024-10-03 iFuse TORQ TNT Navigation Instrument Tray |
| 00810055523498 - Trocar Pin, 2.0 mm x 250 mm, TORQ TNT | 2024-09-25 Trocar Pin, 2.0 mm x 250 mm, TORQ TNT |
| 00810055523504 - Trocar Pin, 2.0 mm x 330 mm, TORQ TNT | 2024-09-25 Trocar Pin, 2.0 mm x 330 mm, TORQ TNT |
| 00810055523511 - Trocar Pin, 2.5 mm x 330 mm | 2024-09-25 Trocar Pin, 2.5 mm x 330 mm |
| 00810055523528 - Drill Pin, 2.5 mm x 330 mm | 2024-09-25 Drill Pin, 2.5 mm x 330 mm |