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Concorde 196923511

by Medos International Sàrl

Ref 196923511

Concorde 196923511 is a device classified as Class IIb in the EU and Class II in the US made by Medos International Sàrl, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-CHMF000014268000239YU), cleared under FDA 510(k) K173787 on 11 Jun 2018 (1 earlier submission) and listed in FDA GUDID since 20 Apr 2016 (UDI-DI D-CHMF000014268000239YU), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173787

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-CHMF000014268000239YU Basic UDI-DI D-CHMF000014268000239YUUDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173787 Date11 Jun 2018DecidedStatusActive
United StatesGUDID listing GUDID NumberD-CHMF000014268000239YU UDI-DI Date20 Apr 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-CHMF000014268000239YU registered 3 Nov 2026 Active
  • FDA 510(k) K173787 decided 11 Jun 2018 Active· +1 more in the status table
  • FDA GUDID UDI-DI D-CHMF000014268000239YU listed 20 Apr 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K151352
  2. Listed FDA GUDID D-CHMF000014268000239YU
  3. Cleared FDA 510(k) K173787
  4. Registered EUDAMED B-CHMF000014268000239YU

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Concorde
Generic name
Metallic spinal interbody fusion cage
Model / Ref / Catalog
196923511
Primary DI / UDI-DI
D-CHMF000014268000239YU EUDAMED
10705034454368 GUDID
Basic UDI-DI
B-CHMF000014268000239YU
510(k) Number
FDA product code
MAX, MQP
EMDN code
P09070101 Spinal cages
GMDN term
Metallic spinal interbody fusion cage
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3080, 888.3060
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-CHMF000014268000239YU
GUDID
10705034454368
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-CHMF000014268000239YU; FDA GUDID lists 10705034454368), so their flags are not compared. 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: Metallic spinal interbody fusion cage

Cleared under the same submission (K151352)

and 2 more cleared under K151352

Cleared under the same submission (K173787)

and 8 more cleared under K173787

Similar devices in this category

Other devices filed under SPINAL CAGES.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)