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Arvis ® In-22100

by Kico Knee Innovation Company Pty Limited

Ref IN-22100

Arvis ® In-22100 is a device classified as Class I in the EU and Class II in the US made by Kico Knee Innovation Company Pty Limited, registered in EUDAMED on 18 May 2026 (Basic UDI-DI 08889120000Z120114800B3G6), cleared under FDA 510(k) K240062 on 29 Apr 2024 and listed in FDA GUDID since 18 Mar 2025 (UDI-DI 00810180350280), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240062

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 Number08889120000Z120114800B3G6 Basic UDI-DI 00810180350280UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810180350280 UDI-DI Date18 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240062 Date29 Apr 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08889120000Z120114800B3G6 registered 18 May 2026 Active
  • FDA 510(k) K240062 decided 29 Apr 2024 Active
  • FDA GUDID UDI-DI 00810180350280 listed 18 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K240062
  2. Listed FDA GUDID 00810180350280
  3. Registered EUDAMED 08889120000Z120114800B3G6

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  • Withdrawn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
Arvis EUDAMED
Arvis ® GUDID
Generic name
Optical surgical tracking system spatial marker, reusable
Device name
Reverse Registration Tool
Model / reference
IN-22100
Primary DI / UDI-DI
00810180350280
Basic UDI-DI
08889120000Z120114800B3G6
Direct marketing DI
00810180350280
510(k) Number
FDA product code
OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Optical surgical tracking system spatial marker, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Surgical optical-tracking spatial marker, reusable

Cleared under the same submission (K240062)

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Kico Knee Innovation Company Pty Limited

See all devices from Kico Knee Innovation Company Pty Limited →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)