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Kick 2 Navigation Station EM, Kick® Navigation, Kick2® Navigation, Kick Navigation EM, Kick Navigation System EM

by Brainlab SE

Ref 18202

Kick 2 Navigation Station EM, Kick® Navigation, Kick2® Navigation, Kick Navigation EM, Kick Navigation System EM (18202) is a device classified as Class IIb in the EU and Class II in the US made by Brainlab SE, registered in EUDAMED on 16 Jul 2025 (Basic UDI-DI 4056481Kick99), cleared under FDA 510(k) K223288 on 21 Jul 2023 (2 earlier submissions) and listed in FDA GUDID since 30 Sep 2022 (UDI-DI 04056481143725), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223288

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4056481Kick99 Basic UDI-DI 04056481143725UDI-DIDate16 Jul 2025RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223288 Date21 Jul 2023DecidedStatusActive
United StatesGUDID listing GUDID Number04056481143725 UDI-DI Date30 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4056481Kick99 registered 16 Jul 2025 Active
  • FDA 510(k) K223288 decided 21 Jul 2023 Active· +2 more in the status table
  • FDA GUDID UDI-DI 04056481143725 listed 30 Sep 2022 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K213989
  2. Listed FDA GUDID 04056481143725
  3. Cleared FDA 510(k) K223734
  4. Cleared FDA 510(k) K223288
  5. Registered EUDAMED 4056481Kick99

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Kick 2 Navigation Station EM, Kick® Navigation, Kick2® Navigation, Kick Navigation EM, Kick Navigation System EM EUDAMED
Kick 2 Navigation Station EM GUDID
Generic name
Electromagnetic/optical surgical navigation/tracking system
Device name
Kick 2 Navigation Station
Model / reference
18202
Primary DI / UDI-DI
04056481143725
Basic UDI-DI
4056481Kick99
510(k) Number
FDA product code
HAW, PGW
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Electromagnetic/optical surgical navigation/tracking system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.4560
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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

Related devices

Category: Neurological stereotactic surgery system

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)