Cleared Traditional

iFuse Implant System- iFuse Navigation

K172268 · SI-BONE, Inc. · Orthopedic

Oct 2017

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K172268 is an FDA 510(k) clearance for the iFuse Implant System- iFuse Navigation, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by SI-BONE, Inc. (San Jose, US). The FDA issued a Cleared decision on October 31, 2017, 96 days after receiving the submission on July 27, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K172268 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 27, 2017
Decision Date	October 31, 2017
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.