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Kite KM2.7109

by Intrauma SpA

Part of a family of 6 devices: see the family page

Ref KM2.7109Model kit.KM2

Kite KM2.7109 is a device classified as Class IIb in the EU and Class II in the US made by Intrauma SpA, registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI 8056693014AK), cleared under FDA 510(k) K230623 on 1 Sep 2023 and listed in FDA GUDID since 2 Oct 2023 (UDI-DI 08056693002021), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230623

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8056693014AK Basic UDI-DI 08056693002021UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056693002021 UDI-DI Date2 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230623 Date1 Sep 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8056693014AK registered 3 Sep 2026 Active
  • FDA 510(k) K230623 decided 1 Sep 2023 Active
  • FDA GUDID UDI-DI 08056693002021 listed 2 Oct 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K230623
  2. Listed FDA GUDID 08056693002021
  3. Registered EUDAMED 8056693014AK

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  • Withdrawn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
KIT - KITE Malleolar Plate (L) Short EUDAMED
Kite GUDID
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
O'nil KITE Sterile Kit
Model / Ref / Catalog
KM2.7109, kit.KM2
Primary DI / UDI-DI
08056693002021
Basic UDI-DI
8056693014AK
510(k) Number
FDA product code
HRS
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Length — 82 Millimeter

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.

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K230623)

and 8 more cleared under K230623

Similar devices in this category

Other devices filed under BONE FIXATION PLATES - OTHER.

Other devices from Intrauma SpA

See all devices from Intrauma SpA →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)