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Neofuse

by In2Bones SAS 20 variants

Ref V35 ST534

Neofuse (V35 ST534) is a device classified as Class IIb in the EU and Class II in the US made by In2Bones SAS, registered in EUDAMED on 20 Apr 2026 (Basic UDI-DI B-03760225716588), cleared under FDA 510(k) K173121 on 28 Nov 2017 and listed in FDA GUDID since 17 Jul 2019 (UDI-DI 03760225716588), active as of 25 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 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760225716588 Basic UDI-DI 03760225716588UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760225716588 UDI-DI Date17 Jul 2019ListedStatusListed 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-03760225716588 registered 20 Apr 2026 Active
  • FDA 510(k) K173121 decided 28 Nov 2017 Active
  • FDA GUDID UDI-DI 03760225716588 listed 17 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173121
  2. Listed FDA GUDID 03760225716588
  3. Registered EUDAMED B-03760225716588

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  • Withdrawn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
Orthopaedic bone screw (non-sliding)
Device name
Neofuse Locking Screw
Model / Ref / Catalog
V35 ST534 EUDAMED
V35 ST526 GUDID
Primary DI / UDI-DI
03760225716588
Basic UDI-DI
B-03760225716588
510(k) Number
FDA product code
HWC
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 26 Millimeter
Outer Diameter — 3.5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
V35 ST534
GUDID
V35 ST526
Device classEUDAMED
Class IIb
GUDID
Class II

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.

Manufacturer details

EUDAMED SRN
FR-MF-000005246

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from In2Bones SAS

See all devices from In2Bones SAS →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)