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Estremo

by Citieffe 7 variants

Part of a family of 40 devices: see the family page

Ref DT030004Model Guide wires

Estremo (DT030004) is a device classified as Class IIa in the EU and Class II in the US made by Citieffe, registered in EUDAMED on 15 Sep 2026 (Basic UDI-DI 803290962107BU), cleared under FDA 510(k) K181540 on 16 Jan 2019 and listed in FDA GUDID since 21 Feb 2020 (UDI-DI 08051739536331), active as of 14 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 14 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181540

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 14 Oct 2026.

Regulatory status

as of registry sync 14 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962107BU Basic UDI-DI 08051739536331UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08051739536331 UDI-DI Date21 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181540 Date16 Jan 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803290962107BU registered 15 Sep 2026 Active
  • FDA 510(k) K181540 decided 16 Jan 2019 Active
  • FDA GUDID UDI-DI 08051739536331 listed 21 Feb 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181540
  2. Listed FDA GUDID 08051739536331
  3. Registered EUDAMED 803290962107BU

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  • Withdrawn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
Surgical Instruments (Iia) EUDAMED
Estremo GUDID
Generic name
Orthopaedic bone wire
Model / Ref / Catalog
Guide wires, DT030004, Guide wire with olive ø3.2x800mm (STERILE)
Primary DI / UDI-DI
08051739536331
Basic UDI-DI
803290962107BU
510(k) Number
FDA product code
HSB
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic bone wire
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Guide wires
DT030004
GUDID
Guide wire with olive ø3.2x800mm (STERILE)
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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 bone wire

Cleared under the same submission (K181540)

and 8 more cleared under K181540

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Citieffe

See all devices from Citieffe →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)