Cleared Traditional

iFuse Implant System?

K190230 · SI-BONE, Inc. · Orthopedic
Apr 2019
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K190230 is an FDA 510(k) clearance for the iFuse 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 April 3, 2019, 56 days after receiving the submission on February 6, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K190230 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2019
Decision Date April 03, 2019
Days to Decision 56 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