Cleared Special

SPINEART Navigation Instrument System

K210472 · Spineart · Orthopedic

Mar 2021

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K210472 is an FDA 510(k) clearance for the SPINEART Navigation Instrument System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Spineart (Plan Les Ouates, CH). The FDA issued a Cleared decision on March 19, 2021, 30 days after receiving the submission on February 17, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K210472 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2021
Decision Date	March 19, 2021
Days to Decision	30 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.