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Arvis ® In-10900

by Kico Knee Innovation Company Pty Limited

Ref IN-10900

Arvis In-10900 is an optical surgical tracking system spatial marker (EU MDR Class I; FDA Class II; FDA product code SBF, Orthopedic Augmented Reality) made by Kico Knee Innovation Company Pty Limited, registered in EUDAMED on 2 Sep 2025 (Basic UDI-DI 08889120000000000L260A053) and listed in FDA GUDID since 17 Sep 2026 (UDI-DI 00810180350143), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00810180350143 UDI-DI Date17 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08889120000000000L260A053 Basic UDI-DI 00810180350143UDI-DIDate2 Sep 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08889120000000000L260A053 registered 2 Sep 2025 Active
  • FDA GUDID UDI-DI 00810180350143 listed 17 Sep 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 08889120000000000L260A053
  2. Listed FDA GUDID 00810180350143

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Arvis ®
Generic name
Optical surgical tracking system spatial marker, reusable
Device name
[ARVIS - Instruments] Hex Driver
Model / reference
IN-10900
Primary DI / UDI-DI
00810180350143
Basic UDI-DI
08889120000000000L260A053
Direct marketing DI
00810180350143
FDA product code
SBF
EMDN code
L26 Surgical screwdrivers, reusable
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.

Similar devices in this category

Other devices filed under SURGICAL SCREWDRIVERS, REUSABLE.

Other devices from Kico Knee Innovation Company Pty Limited

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Properties

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