Cleared Special

SI-BONE iFuse Implant System

K150714 · SI-BONE, Inc. · Orthopedic
Apr 2015
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K150714 is an FDA 510(k) clearance for the SI-BONE 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 April 17, 2015, 29 days after receiving the submission on March 19, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K150714 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2015
Decision Date April 17, 2015
Days to Decision 29 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