Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K203247
iFuse-TORQ Implant System · SI-BONE, Inc. · decided 2021-02-25 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| iFuse TORQ Implant System-10.75 mm Tap, Cannulated | 501157-1075 | Si-Bone Inc. | OUR | 00855369008460 |
| iFuse TORQ Implant System | 11580LG | Si-Bone Inc. | OUR | 00810055520473 |
| iFuse TORQ Implant System | 11545T | Si-Bone Inc. | OUR | 00810055520299 |
| iFuse TORQ Implant System | 13545LG | Si-Bone Inc. | OUR | 00810055520640 |
| iFuse TORQ Implant System | 13580LG | Si-Bone Inc. | OUR | 00810055520718 |
| iFuse TORQ Implant System | 11550LG | Si-Bone Inc. | OUR | 00810055520411 |
| iFuse TORQ Implant System-Driver Sleeve 2 | 400262 | Si-Bone Inc. | OUR | 00855369008514 |
| iFuse TORQ Implant System | 13560LG | Si-Bone Inc. | OUR | 00810055520671 |
| iFuse TORQ Implant System | 11560LG | Si-Bone Inc. | OUR | 00810055520435 |
| iFuse TORQ Implant System-10.75 mm Navigation Tap, Awl Tip | 501126-1075 | Si-Bone Inc. | OUR | 00855369008606 |
| iFuse TORQ Implant System | 10085LG | Si-Bone Inc. | OUR | 00810055520244 |
| iFuse TORQ Implant System | 10075LG | Si-Bone Inc. | OUR | 00810055520220 |
| iFuse TORQ Implant System | 11565T | Si-Bone Inc. | OUR | 00810055520336 |
| iFuse TORQ Implant System-iFuse-TORQ Instrument Set, Revision | 400289 | Si-Bone Inc. | OUR | 00810055520015 |
| iFuse TORQ Implant System | 11535T | Si-Bone Inc. | OUR | 00810055520275 |
| iFuse TORQ Implant System | 11590T | Si-Bone Inc. | OUR | 00810055520381 |
| iFuse TORQ Implant System | 10090T | Si-Bone Inc. | OUR | 00810055520145 |
| iFuse TORQ Implant System | 10050LG | Si-Bone Inc. | OUR | 00810055520176 |
| iFuse TORQ Implant System | 10035T | Si-Bone Inc. | OUR | 00810055520039 |
| iFuse TORQ Implant System | 10080LG | Si-Bone Inc. | OUR | 00810055520237 |
| iFuse TORQ Implant System-9.25 mm Navigation Tap, Cannulated | 501124-0925 | Si-Bone Inc. | OUR | 00855369008576 |
| iFuse TORQ Implant System | 13550LG | Si-Bone Inc. | OUR | 00810055520657 |
| iFuse TORQ Implant System | 13590T | Si-Bone Inc. | OUR | 00810055520626 |
| iFuse TORQ Implant System | 11555LG | Si-Bone Inc. | OUR | 00810055520428 |
| iFuse TORQ Implant System | 11540LG | Si-Bone Inc. | OUR | 00810055520398 |