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FDA 510(k)

RIWOtrack Navigation System

K-Number: K230700 · 2023-11-20

ApplicantFiagon GmbH
Decision Date2023-11-20
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RIWOtrack Navigation System is a medical device manufactured by Fiagon GmbH. It received FDA 510(k) clearance on 2023-11-20 under approval number K230700. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIWOtrack Navigation System?

RIWOtrack Navigation System is a medical device that received FDA 510(k) clearance on 2023-11-20. It is manufactured by Fiagon GmbH. The 510(k) number is K230700.

When was RIWOtrack Navigation System approved by the FDA?

RIWOtrack Navigation System received FDA 510(k) clearance on 2023-11-20, under approval number K230700.

What company makes RIWOtrack Navigation System?

RIWOtrack Navigation System is manufactured by Fiagon GmbH.

What is the FDA product code for RIWOtrack Navigation System?

The FDA product code for RIWOtrack Navigation System is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT06895187 Catheter Ablation Using a Novel Navigation and Imaging System NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Fiagon GmbH

K162176Fiagon Navigation System K161940Guidewire 0.6 Single Use K151156Fiagon Navigation System K160479PointerShell Universal, PointerShell LS K160369GuideWire K163209Fiagon Navigation System

View all 12 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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