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 IDK213667
510k NumberK213667
Device Name:IFuse-TORQ® Implant System
ClassificationSacroiliac Joint Fixation
Applicant SI-BONE, Inc. 471 El Camino Real, Suite 101 Santa Clara,  CA  95050
ContactMeirav Harsat
CorrespondentMeirav Harsat
SI-BONE, Inc. 471 El Camino Real, Suite 101 Santa Clara,  CA  95050
Product CodeOUR  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-22
Decision Date2022-06-10

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