Cleared Traditional

iFuse-TORQ? Implant System

K213667 · SI-BONE, Inc. · Orthopedic
Jun 2022
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K213667 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 10, 2022, 200 days after receiving the submission on November 22, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K213667 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2021
Decision Date June 10, 2022
Days to Decision 200 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