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EBA2 End cap + 15 mm

by Citieffe

Ref EBA-6015Model End cap

EBA2 End cap + 15 mm (EBA-6015) is a bone nail implantable cap (EU MDR Class IIb; FDA Class II; FDA product code HSB, Rod, Fixation, Intramedullary And Accessories) made by Citieffe, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 803290962055C2), cleared under FDA 510(k) K131005 on 25 Jun 2013 and listed in FDA GUDID since 5 Aug 2016 (UDI-DI 08032909629589), active as of 23 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 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962055C2 Basic UDI-DI 08032909629589UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08032909629589 UDI-DI Date5 Aug 2016ListedStatusListed 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 803290962055C2 registered 23 Sep 2026 Active
  • FDA 510(k) K131005 decided 25 Jun 2013 Active
  • FDA GUDID UDI-DI 08032909629589 listed 5 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131005
  2. Listed FDA GUDID 08032909629589
  3. Registered EUDAMED 803290962055C2

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  • Withdrawn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
Bone nail implantable cap
Device name
End cap
Model / Ref / Catalog
End cap, EBA-6015, End cap + 15 mm
Description
End cap for femoral nail. Lenght: Standard cap + 15 mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
Primary DI / UDI-DI
08032909629589
Basic UDI-DI
803290962055C2
510(k) Number
FDA product code
HSB
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Bone nail implantable cap
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
End cap
EBA-6015
GUDID
End cap + 15 mm
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: Bone nail end-cap

Cleared under the same submission (K131005)

and 8 more cleared under K131005

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

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)