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EBA2 Cortical screw ø5mm L30mm

by Citieffe

Part of a family of 51 devices: see the family page

Ref EBA-9030Model Locking Screw

EBA2 Cortical screw ø5mm L30mm (EBA-9030) is a device classified as Class IIb in the EU and Class II in the US made by Citieffe, registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI 803290962047C3), cleared under FDA 510(k) K131005 on 25 Jun 2013 and listed in FDA GUDID since 21 Oct 2015 (UDI-DI 08032909627400), 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) K131005

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 Number803290962047C3 Basic UDI-DI 08032909627400UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08032909627400 UDI-DI Date21 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK131005 Date25 Jun 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803290962047C3 registered 12 Oct 2026 Active
  • FDA 510(k) K131005 decided 25 Jun 2013 Active
  • FDA GUDID UDI-DI 08032909627400 listed 21 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131005
  2. Listed FDA GUDID 08032909627400
  3. Registered EUDAMED 803290962047C3

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  • Withdrawn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
EBA2
Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Device name
Locking Screw
Model / Ref / Catalog
Locking Screw, EBA-9030, Cortical screw ø5mm L30mm
Description
Cortical screw ø5mm L30mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
Primary DI / UDI-DI
08032909627400
Basic UDI-DI
803290962047C3
510(k) Number
FDA product code
HSB
EMDN code
P09120601 Cortical screws
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
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
Size
Length — 30 Millimeter
Outer Diameter — 5 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Locking Screw
EBA-9030
GUDID
Cortical screw ø5mm L30mm
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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 bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K131005)

and 8 more cleared under K131005

Similar devices in this category

Other devices filed under CORTICAL SCREWS.

Other devices from Citieffe

See all devices from Citieffe →

Properties

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