Cleared Special

iFuse TORQ? Implant System

K222605 · SI-BONE, Inc. · Orthopedic
Sep 2022
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K222605 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 September 29, 2022, 31 days after receiving the submission on August 29, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K222605 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2022
Decision Date September 29, 2022
Days to Decision 31 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