Skip to content

Idys™- PLIF 04705011

by Clariance, Inc.

Ref 04705011Model Spinal instrumentation

Idys™- PLIF 04705011 is a device classified as Class I in the EU and Class II in the US made by Clariance, Inc., registered in EUDAMED on 7 Jul 2026 (Basic UDI-DI 0370078069980OSHG) and listed in FDA GUDID since 21 May 2018 (UDI-DI 03700780628537), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0370078069980OSHG Basic UDI-DI 03700780628537UDI-DIDate7 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700780628537 UDI-DI Date21 May 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0370078069980OSHG registered 7 Jul 2026 Active
  • FDA GUDID UDI-DI 03700780628537 listed 21 May 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700780628537
  2. Registered EUDAMED 0370078069980OSHG

Coverage

2 jurisdictions

United States of AmericaFrance
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

EU market availability

Made available in 1 country, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • France since 1 Jan 2019

Last checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade name
Ostéotome Courbé EUDAMED
Idys™- PLIF GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
04705011, Spinal instrumentation
Primary DI / UDI-DI
03700780628537
Basic UDI-DI
0370078069980OSHG
FDA product code
MAX
EMDN code
P090799 Spinal prostheses and stabilisation systems - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3080
EU registration type
Standard device
EU market of registration
France
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Orthopaedic surgical procedure kit, non-medicated, reusable

Similar devices in this category

Other devices filed under SPINAL PROSTHESES AND STABILISATION SYSTEMS - OTHER.

Other devices from Clariance, Inc.

See all devices from Clariance, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)