Skip to content

Mixed Reality Spine Navigation, 1.0

by Brainlab SE

Ref 04056481143985

Mixed Reality Spine Navigation, 1.0 (04056481143985) is a device classified as Class IIb in the EU and Class II in the US made by Brainlab SE, registered in EUDAMED on 1 Jul 2025 (Basic UDI-DI 4056481MixedRealitySpMU), cleared under FDA 510(k) K242569 on 16 May 2025 and listed in FDA GUDID since 31 May 2025 (UDI-DI 04056481143985), withdrawn (EUDAMED), active (FDA 510(k)), not in commercial distribution (GUDID) as of 25 Oct 2026.

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242569

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4056481MixedRealitySpMU Basic UDI-DI 04056481143985UDI-DIDate1 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number04056481143985 UDI-DI Date31 May 2025ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK242569 Date16 May 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4056481MixedRealitySpMU registered 1 Jul 2025 Withdrawn
  • FDA 510(k) K242569 decided 16 May 2025 Active
  • FDA GUDID UDI-DI 04056481143985 listed 31 May 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K242569
  2. Listed FDA GUDID 04056481143985
  3. Registered EUDAMED 4056481MixedRealitySpMU

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Mixed Reality Spine Navigation, 1.0 EUDAMED
Mixed Reality Spine Navigation GUDID
Generic name
Electromagnetic/optical surgical navigation/tracking system
Model / reference
04056481143985 EUDAMED
1.0 GUDID
Primary DI / UDI-DI
04056481143985
Basic UDI-DI
4056481MixedRealitySpMU
Direct marketing DI
04056481143985
510(k) Number
FDA product code
SBF
EMDN code
Z12011482 Surgical navigation instruments - software accessories
GMDN term
Electromagnetic/optical surgical navigation/tracking system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.4560
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04056481143985
GUDID
1.0
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
DE-MF-000006183

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)