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Estremo

by Citieffe 7 variants

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

Ref EBA-5316Model Aligners-compactors

Estremo (EBA-5316) is a device classified as Class I in the EU and Class II in the US made by Citieffe, registered in EUDAMED on 8 Sep 2026 (Basic UDI-DI 803290962111BK), cleared under FDA 510(k) K181540 on 16 Jan 2019 and listed in FDA GUDID since 7 Feb 2019 (UDI-DI 08052990979745), active as of 7 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 7 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 7 Oct 2026.

Regulatory status

as of registry sync 7 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962111BK Basic UDI-DI 08052990979745UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08052990979745 UDI-DI Date7 Feb 2019ListedStatusListed 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 803290962111BK registered 8 Sep 2026 Active
  • FDA 510(k) K181540 decided 16 Jan 2019 Active
  • FDA GUDID UDI-DI 08052990979745 listed 7 Feb 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181540
  2. Listed FDA GUDID 08052990979745
  3. Registered EUDAMED 803290962111BK

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  • Withdrawn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 (Ir) EUDAMED
Estremo GUDID
Generic name
Orthopaedic bone-fragment manipulator, reusable
Model / Ref / Catalog
Aligners-compactors, EBA-5316, Fracture alignment guide wire exchange tool
Primary DI / UDI-DI
08052990979745
Basic UDI-DI
803290962111BK
Direct marketing DI
08052990979745
510(k) Number
FDA product code
HSB
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Orthopaedic bone-fragment manipulator, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3020
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Aligners-compactors
EBA-5316
GUDID
Fracture alignment guide wire exchange tool
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: Orthopaedic bone-fragment manipulator, reusable

Cleared under the same submission (K181540)

and 8 more cleared under K181540

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Citieffe

See all devices from Citieffe →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)