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: K203247
• 510k Number: K203247
• 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: Susan Noriega
• Correspondent: Susan Noriega; SI-BONE, Inc. 471 El Camino Real, Suite 101 Santa Clara, CA 95050
• Product Code: OUR
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-11-04
• Decision Date: 2021-02-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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