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Crossnav Navigation Enabled Instruments and Unas Navigation Arrays

by Medos International SARL EUDAMED510(k)GUDID

Active European Union and United States

510(k) K241893Ref 3020-20-001Model Spinal Navigation Adaptors and Arrays CROSSNAV Adaptor

Overview

The Crossnav Navigation Enabled Instruments and UNAS Navigation Arrays are navigation-enabled surgical instruments designed for precise intraoperative guidance. These devices integrate electromagnetic tracking technology to provide real-time spatial orientation, enhancing accuracy during procedures such as deep brain stimulation, neurosurgical interventions, or other minimally invasive techniques requiring spatial precision.

Supplied as reusable instruments with integrated navigation arrays, these devices are intended for use in sterile operating room environments. They require compatibility with electromagnetic navigation systems and are not MRI-safe. The instruments are regulated under FDA 510K clearance (K241893) and comply with MDR requirements, ensuring adherence to stringent safety and performance standards for surgical navigation tools.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a0025465 Basic UDI-DIDate24 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034604572 UDI-DIDate14 Feb 2025ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241893 Date16 Sep 2024ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Crossnav
Generic Name
Optical surgical tracking system spatial marker connector
Device Name
CROSSNAV Adaptor
Model / Reference
3020-20-001, Spinal Navigation Adaptors and Arrays CROSSNAV Adaptor
Primary DI / UDI-DI
10705034604572
Basic UDI-DI
0705034a0025465
Direct Marketing DI
10705034604572
510(k) Number
FDA Product Code
OLO
EMDN Code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN Term
Optical surgical tracking system spatial marker connector
Device Class
Class I EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 882.4560
Market of Registration
Belgium
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class I
510(k)
Class II
GUDID
Class II

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Questions

  • Are the Crossnav Navigation Enabled Instruments reusable or single-use, and how should they be handled in the operating room?

    The Crossnav Navigation Enabled Instruments are designed as reusable devices, intended for use in sterile operating room environments. Since they integrate navigation arrays, proper cleaning, sterilization, and maintenance procedures must be followed to ensure accuracy and functionality between uses. The electromagnetic tracking components require careful handling to avoid damage, and compatibility with electromagnetic navigation systems is essential for reliable performance.

  • What types of surgical procedures are these instruments primarily used for, and why is electromagnetic tracking important in those cases?

    These instruments are primarily used for deep brain stimulation, neurosurgical interventions, and other minimally invasive procedures where spatial precision is critical. Electromagnetic tracking provides real-time spatial orientation, reducing human error and improving accuracy during delicate manipulations. This is particularly valuable in procedures where even minor deviations could impact patient outcomes, such as electrode placement in neurosurgery.

  • Do these instruments work with MRI machines, and if not, what alternatives should clinicians consider for imaging during procedures?

    No, the Crossnav Navigation Enabled Instruments are not MRI-safe. Clinicians should rely on electromagnetic navigation systems for intraoperative guidance rather than MRI. Alternatives for imaging during procedures may include CT scans, fluoroscopy, or ultrasound, depending on the specific clinical workflow and the requirements of the procedure being performed.

  • How do I verify compatibility with electromagnetic navigation systems before using these instruments?

    Compatibility with electromagnetic navigation systems is a critical requirement for these instruments to function correctly. Before use, ensure the system you’re employing is certified to work with the Crossnav Navigation Arrays. Medos International SARL or their authorized distributors can provide guidance on supported systems, and some navigation platforms may require specific calibration or firmware updates to integrate seamlessly with the reusable instruments.

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No