Cleared Traditional

iFuse TORQ TNT? Implant System

K241504 · SI-BONE, Inc. · Orthopedic
Aug 2024
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K241504 is an FDA 510(k) clearance for the iFuse TORQ TNT? 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 August 19, 2024, 83 days after receiving the submission on May 28, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K241504 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2024
Decision Date August 19, 2024
Days to Decision 83 days
Submission Type Traditional
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