Cleared Traditional

iFuse-TORQ? Implant System

K203247 · SI-BONE, Inc. · Orthopedic
Feb 2021
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K203247 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 February 25, 2021, 113 days after receiving the submission on November 4, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K203247 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 2020
Decision Date February 25, 2021
Days to Decision 113 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