IFuse TORQ® Implant System
Sacroiliac Joint Fixation
SI-BONE, Inc.
The following data is part of a premarket notification filed by Si-bone, Inc. with the FDA for Ifuse Torq® Implant System.
Pre-market Notification Details
| Device ID | K222605 |
| 510k Number | K222605 |
| Device Name: | IFuse TORQ® Implant System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | SI-BONE, Inc. 471 El Camino Real Suite 101 Santa Clara, CA 95050 |
| Contact | Meirav Harsat |
| Correspondent | Meirav Harsat SI-BONE, Inc. 471 El Camino Real Suite 101 Santa Clara, CA 95050 |
| Product Code | OUR |
| Subsequent Product Code | HWC |
| Subsequent Product Code | OLO |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-29 |
| Decision Date | 2022-09-29 |
Trademark Results [IFuse TORQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IFUSE TORQ 88901165 not registered Live/Pending |
SI-BONE, Inc. 2020-05-05 |
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