Cleared Traditional

iFuse Implant System? - iFuse-3D implant

K162733 · SI-BONE, Inc. · Orthopedic
Mar 2017
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K162733 is an FDA 510(k) clearance for the iFuse Implant System? - iFuse-3D implant, 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 March 10, 2017, 162 days after receiving the submission on September 29, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K162733 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2016
Decision Date March 10, 2017
Days to Decision 162 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