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Neofuse

by In2Bones SAS 3 variants

Ref G01 00351

Neofuse (G01 00351) 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-03760225717158), cleared under FDA 510(k) K173121 on 28 Nov 2017 and listed in FDA GUDID since 11 Jun 2020 (UDI-DI 03760225717158), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173121

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760225717158 Basic UDI-DI 03760225717158UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760225717158 UDI-DI Date11 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173121 Date28 Nov 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760225717158 registered 24 Apr 2026 Active
  • FDA 510(k) K173121 decided 28 Nov 2017 Active
  • FDA GUDID UDI-DI 03760225717158 listed 11 Jun 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173121
  2. Listed FDA GUDID 03760225717158
  3. Registered EUDAMED B-03760225717158

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  • Withdrawn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

Generic name
Surgical screwdriver, reusable
Device name
Percutaneous Burrs
Model / Ref / Catalog
G01 00351
Primary DI / UDI-DI
03760225717158
Basic UDI-DI
B-03760225717158
510(k) Number
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

  • Neofit®

    Class IIb

  • Ibs™

    Class IIb

  • Kirschner wire

    Class IIb

  • Neosys

    Class IIa

See all devices from In2Bones SAS →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)