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