Cleared Traditional

RIWOtrack Navigation System

K230700 · Fiagon GmbH · Orthopedic
Nov 2023
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K230700 is an FDA 510(k) clearance for the RIWOtrack Navigation System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on November 20, 2023, 252 days after receiving the submission on March 13, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K230700 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2023
Decision Date November 20, 2023
Days to Decision 252 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.

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