Cleared Special

iFuse TORQ? Implant System

K231689 · SI-BONE, Inc. · Orthopedic
Jun 2023
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K231689 is an FDA 510(k) clearance for the iFuse TORQ? Implant System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by SI-BONE, Inc. (Santa Clara, US). The FDA issued a Cleared decision on June 30, 2023, 21 days after receiving the submission on June 9, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231689 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2023
Decision Date June 30, 2023
Days to Decision 21 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OUR — Sacroiliac Joint Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion