Cleared Traditional

iFUSE Implant System

K160652 · SI-BONE, Inc. · Orthopedic
Jun 2016
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K160652 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 June 3, 2016, 87 days after receiving the submission on March 8, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K160652 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2016
Decision Date June 03, 2016
Days to Decision 87 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