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trial implant ELO640008T

by Joimax GmbH

Part of a family of 8 devices: see the family page

Ref ELO640008T

trial implant ELO640008T is a device classified as Class IIa in the EU and Class II in the US made by Joimax GmbH, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 42503371INCATRIEC), cleared under FDA 510(k) K151143 on 9 Jul 2015 and listed in FDA GUDID since 30 Dec 2022 (UDI-DI 04250337111139), active as of 12 Nov 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151143

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42503371INCATRIEC Basic UDI-DI 04250337111139UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337111139 UDI-DI Date30 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151143 Date9 Jul 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 42503371INCATRIEC registered 21 May 2026 Active
  • FDA 510(k) K151143 decided 9 Jul 2015 Active
  • FDA GUDID UDI-DI 04250337111139 listed 30 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151143
  2. Listed FDA GUDID 04250337111139
  3. Registered EUDAMED 42503371INCATRIEC

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  • Withdrawn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
Trial Implant Cages 08 EUDAMED
trial implant GUDID
Generic name
Internal spinal fixation procedure kit, reusable
Model / Ref / Catalog
ELO640008T
Primary DI / UDI-DI
04250337111139
Basic UDI-DI
42503371INCATRIEC
Direct marketing DI
04250337111139
510(k) Number
FDA product code
MAX
EMDN code
L1199 Neurosurgery instruments, reusable - other
GMDN term
Internal spinal fixation procedure kit, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3080
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Internal spinal fixation procedure kit, reusable

Cleared under the same submission (K151143)

and 8 more cleared under K151143

Similar devices in this category

Other devices filed under NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Joimax GmbH

See all devices from Joimax GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)