Concorde 187827513: CE/MDD Class IIb

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-CHMF000014268000091YL Basic UDI-DI D-CHMF000014268000091YLUDI-DI	Date3 Nov 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK173787	Date11 Jun 2018Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK151773	Date20 Nov 2015Decided	StatusActive
United States	GUDID listing GUDID	NumberD-CHMF000014268000091YL UDI-DI	Date24 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK081917	Date22 May 2009Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK052746	Date21 Oct 2005Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK041722	Date23 Sep 2004Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-CHMF000014268000091YL — open Devices and search for it
AccessGUDID record UDI-DI 10705034140209
FDA 510(k) database 510(k) number K173787
FDA 510(k) database 510(k) number K151773
FDA 510(k) database 510(k) number K081917
FDA 510(k) database 510(k) number K052746
FDA 510(k) database 510(k) number K041722

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-CHMF000014268000091YL registered 3 Nov 2026 Active
FDA 510(k) K173787 decided 11 Jun 2018 Active· +4 more in the status table
FDA GUDID UDI-DI D-CHMF000014268000091YL listed 24 Sep 2015 Listed

Timeline

7 dated events

23 Sep 2004 Cleared FDA 510(k) K041722
21 Oct 2005 Cleared FDA 510(k) K052746
22 May 2009 Cleared FDA 510(k) K081917
24 Sep 2015 Listed FDA GUDID D-CHMF000014268000091YL
20 Nov 2015 Cleared FDA 510(k) K151773
11 Jun 2018 Cleared FDA 510(k) K173787
3 Nov 2026 Registered EUDAMED B-CHMF000014268000091YL

Coverage

2 jurisdictions

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Withdrawn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: Polymeric spinal interbody fusion cage
Model / Ref / Catalog: 187827513

Primary DI / UDI-DI: D-CHMF000014268000091YL EUDAMED
10705034140209 GUDID
Basic UDI-DI: B-CHMF000014268000091YL
510(k) Number: K041722
K052746
K081917
K151773
K173787
FDA product code: MQP, MAX
EMDN code: P09070101 Spinal cages
GMDN term: Polymeric spinal interbody fusion cage

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 888.3060, 888.3080
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

Field	EUDAMED	GUDID
Primary DI / UDI-DI	EUDAMED D-CHMF000014268000091YL	GUDID 10705034140209
Device class	EUDAMED Class IIb	GUDID Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-CHMF000014268000091YL; FDA GUDID lists 10705034140209), 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.

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K041722)

and 8 more cleared under K041722

Cleared under the same submission (K052746)

and 8 more cleared under K052746

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® XLC550800 — INNO Holdings, Inc. Class II
CoRoent 5150342 — NuVasive, LLC Class II
Novel Spinal Spacer System 64353-340 — ALPHATEC SPINE, INC. Class II
S-LIFT® IM50052-05 — SPINEFRONTIER, INC. Class II
Peridot Intervertebral body fusion system L363-D906 — GBS Commonwealth Co., Ltd. Class II

Similar devices in this category

Other devices filed under SPINAL CAGES.

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Properties

Sterilise before use
Single use
Implantable
Prescription use
Lot / batch number

Other properties (20, all answered No)