Cleared Special

iFuse TORQ? Implant System

K241574 · SI-BONE, Inc. · Orthopedic
Jul 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K241574 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 July 2, 2024, 29 days after receiving the submission on June 3, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K241574 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2024
Decision Date July 02, 2024
Days to Decision 29 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