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Triway

by In2Bones SAS 12 variants

Ref N20 ST580

Triway (N20 ST580) is a device classified as Class IIb in the EU and Class II in the US made by In2Bones SAS, registered in EUDAMED on 17 Apr 2026 (Basic UDI-DI B-03760225717783), cleared under FDA 510(k) K173811 on 15 Mar 2018 and listed in FDA GUDID since 6 Mar 2019 (UDI-DI 03760225717783), 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) K173811

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-03760225717783 Basic UDI-DI 03760225717783UDI-DIDate17 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760225717783 UDI-DI Date6 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173811 Date15 Mar 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760225717783 registered 17 Apr 2026 Active
  • FDA 510(k) K173811 decided 15 Mar 2018 Active
  • FDA GUDID UDI-DI 03760225717783 listed 6 Mar 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173811
  2. Listed FDA GUDID 03760225717783
  3. Registered EUDAMED B-03760225717783

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  • Withdrawn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)
Model / Ref / Catalog
N20 ST580
Primary DI / UDI-DI
03760225717783
Basic UDI-DI
B-03760225717783
510(k) Number
FDA product code
HWC
EMDN code
P09120299 Osteosynthesis nails - other
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
Size
Length — 80 Millimeter
Outer Diameter — 5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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 NAILS - OTHER.

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Properties

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