Cougar 189150408: CE/MDD Class IIb, Medos International Sàrl

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-CHMF000014268000226YK Basic UDI-DI D-CHMF000014268000226YKUDI-DI	Date3 Nov 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK173787	Date11 Jun 2018Decided	StatusActive
United States	GUDID listing GUDID	NumberD-CHMF000014268000226YK UDI-DI	Date24 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK082128	Date14 Nov 2008Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-CHMF000014268000226YK — open Devices and search for it
AccessGUDID record UDI-DI 10705034164472
FDA 510(k) database 510(k) number K173787
FDA 510(k) database 510(k) number K082128

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-CHMF000014268000226YK 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-CHMF000014268000226YK listed 24 Sep 2015 Listed

Timeline

4 dated events

14 Nov 2008 Cleared FDA 510(k) K082128
24 Sep 2015 Listed FDA GUDID D-CHMF000014268000226YK
11 Jun 2018 Cleared FDA 510(k) K173787
3 Nov 2026 Registered EUDAMED B-CHMF000014268000226YK

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Withdrawn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: Cougar
Generic name: Polymeric spinal interbody fusion cage
Model / Ref / Catalog: 189150408

Primary DI / UDI-DI: D-CHMF000014268000226YK EUDAMED
10705034164472 GUDID
Basic UDI-DI: B-CHMF000014268000226YK
510(k) Number: K082128
K173787
FDA product code: MAX
EMDN code: P09070101 Spinal cages
GMDN term: Polymeric spinal interbody fusion cage

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 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-CHMF000014268000226YK	GUDID 10705034164472
Device class	EUDAMED Class IIb	GUDID Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-CHMF000014268000226YK; FDA GUDID lists 10705034164472), 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 (K082128)

and 8 more cleared under K082128

Cleared under the same submission (K173787)

and 8 more cleared under K173787

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

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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)