Cleared Traditional

iFuse Implant System

K150875 · SI-BONE, Inc. · Orthopedic
Jul 2015
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K150875 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 July 22, 2015, 112 days after receiving the submission on April 1, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K150875 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2015
Decision Date July 22, 2015
Days to Decision 112 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