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Ibs™

by In2Bones SAS 25 variants

Ref G01 00261

Ibs™ (G01 00261) is a device classified as Class IIa in the EU and Class I in the US made by In2Bones SAS, registered in EUDAMED on 24 Apr 2026 (Basic UDI-DI B-03760225715970) and listed in FDA GUDID since 11 Jun 2020 (UDI-DI 03760225715970), active as of 25 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-03760225715970 Basic UDI-DI 03760225715970UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760225715970 UDI-DI Date11 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03760225715970 registered 24 Apr 2026 Active
  • FDA GUDID UDI-DI 03760225715970 listed 11 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760225715970
  2. Registered EUDAMED B-03760225715970

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Surgical screwdriver, reusable
Device name
NEOFUSE® Arthrodesis PLATING SYSTEM
Model / Ref / Catalog
G01 00261
Primary DI / UDI-DI
03760225715970
Basic UDI-DI
B-03760225715970
FDA product code
HXX
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Surgical screwdriver, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
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 · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FR-MF-000005246

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from In2Bones SAS

See all devices from In2Bones SAS →

Properties

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