Cleared Traditional

iFuse Implant System

K151718 · SI-BONE, Inc. · Orthopedic
Oct 2015
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K151718 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. (San Jose, US). The FDA issued a Cleared decision on October 29, 2015, 126 days after receiving the submission on June 25, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K151718 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2015
Decision Date October 29, 2015
Days to Decision 126 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