Cleared Special

iFuse Implant System - iFuse Navigation

K203110 · SI-BONE, Inc. · Orthopedic

Nov 2020

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K203110 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. (Santa Clara, US). The FDA issued a Cleared decision on November 9, 2020, 25 days after receiving the submission on October 15, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K203110 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 2020
Decision Date	November 09, 2020
Days to Decision	25 days
Submission Type	Special
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.