RIWOtrack Cube4D

FDA UDI

Class II (US FDA UDI)

by Fiagon GmbH

Identity

Trade Name: RIWOtrack Cube4D FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: Navigation unit, Component of RIWOtrack Navigation System FDA UDI
Model / Reference: E011106-HD/8 RW FDA UDI
Description: Navigation unit, Component of RIWOtrack Navigation System FDA UDI

Identifiers

Catalog Number: E011106-HD/8 RW FDA UDI
Primary DI / UDI-DI: 04260759931567 FDA UDI
510(k) Number: K230700 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Multi-purpose stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Multi-purpose stereotactic surgery system

RIWOtrack Cube4D by Fiagon GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Multi-purpose stereotactic surgery system.

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Mo¨ller® — MEDTRONIC NAVIGATION, INC. · Class II
StealthStation® S7® — MEDTRONIC NAVIGATION, INC. · Class II
NIM-Spine — MEDTRONIC SOFAMOR DANEK, INC. · Class II
UNIVERSAL NAVIGATION VIPER SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
NAVIGATION ENABLED INSTRUMENTS — MEDOS INTERNATIONAL SARL · Class IIa

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fiagon GmbH

Sources (1)

FDA UDI 942af497-9ce6-44f8-96ef-894e982e1b75 35 fields · synced May 30, 2026