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EBA ONE Long nail ø12x320mm 130° right

by Citieffe

Part of a family of 282 devices: see the family page

Ref EBA-562232Model Nail

EBA ONE Long nail ø12x320mm 130° right (EBA-562232) is a device classified as Class IIb in the EU and Class II in the US made by Citieffe, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 803290962044BV), cleared under FDA 510(k) K183666 on 14 Nov 2019 and listed in FDA GUDID since 16 Dec 2019 (UDI-DI 08052990978359), 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) K183666

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 Number803290962044BV Basic UDI-DI 08052990978359UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08052990978359 UDI-DI Date16 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183666 Date14 Nov 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803290962044BV registered 13 Oct 2026 Active
  • FDA 510(k) K183666 decided 14 Nov 2019 Active
  • FDA GUDID UDI-DI 08052990978359 listed 16 Dec 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183666
  2. Listed FDA GUDID 08052990978359
  3. Registered EUDAMED 803290962044BV

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  • Withdrawn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
Eba One
Generic name
Femur intramedullary nail
Model / Ref / Catalog
Nail, EBA-562232, Long nail ø12x320mm 130° right
Primary DI / UDI-DI
08052990978359
Basic UDI-DI
803290962044BV
510(k) Number
FDA product code
HSB
EMDN code
P09120201 Intramedullary nails
GMDN term
Femur intramedullary nail
Device class
Class IIb 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
Nail
EBA-562232
GUDID
Long nail ø12x320mm 130° right
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: Femur intramedullary nail

Cleared under the same submission (K183666)

and 8 more cleared under K183666

Similar devices in this category

Other devices filed under INTRAMEDULLARY NAILS.

Other devices from Citieffe

See all devices from Citieffe →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)