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ESTREMO nail ø8x380mm

by Citieffe

Part of a family of 101 devices: see the family page

Ref DT308380Model Nail

ESTREMO nail ø8x380mm (DT308380) 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 803290962001BB), cleared under FDA 510(k) K181540 on 16 Jan 2019 and listed in FDA GUDID since 7 Feb 2019 (UDI-DI 08052990974726), active as of 25 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 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962001BB Basic UDI-DI 08052990974726UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08052990974726 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 803290962001BB registered 13 Oct 2026 Active
  • FDA 510(k) K181540 decided 16 Jan 2019 Active
  • FDA GUDID UDI-DI 08052990974726 listed 7 Feb 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181540
  2. Listed FDA GUDID 08052990974726
  3. Registered EUDAMED 803290962001BB

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  • Withdrawn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
Estremo
Generic name
Tibia intramedullary nail
Model / Ref / Catalog
Nail, DT308380, ESTREMO nail ø8x380mm
Primary DI / UDI-DI
08052990974726
Basic UDI-DI
803290962001BB
510(k) Number
FDA product code
HSB
EMDN code
P09120201 Intramedullary nails
GMDN term
Tibia 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
DT308380
GUDID
ESTREMO nail ø8x380mm
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: Tibia intramedullary nail

Cleared under the same submission (K181540)

and 8 more cleared under K181540

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
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)