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Kirschner wire

by In2Bones SAS 14 variants

Ref K21 NS100

Kirschner wire (K21 NS100) 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-03760225715611), cleared under FDA 510(k) K153204 on 1 Feb 2016 and listed in FDA GUDID since 18 Mar 2016 (UDI-DI 03760225715611), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153204

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760225715611 Basic UDI-DI 03760225715611UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760225715611 UDI-DI Date18 Mar 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK153204 Date1 Feb 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760225715611 registered 20 Apr 2026 Active
  • FDA 510(k) K153204 decided 1 Feb 2016 Active
  • FDA GUDID UDI-DI 03760225715611 listed 18 Mar 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153204
  2. Listed FDA GUDID 03760225715611
  3. Registered EUDAMED B-03760225715611

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  • Withdrawn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 pin, non-bioabsorbable
Model / Ref / Catalog
K21 NS100
Primary DI / UDI-DI
03760225715611
Basic UDI-DI
B-03760225715611
510(k) Number
FDA product code
HTY, FZX, JDW
EMDN code
P09120301 Kirschner bone wires
GMDN term
Orthopaedic bone pin, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040, 878.4800
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
MRI safety
MR Conditional
Size
Length — 100 Millimeter
Outer Diameter — 1.0 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 KIRSCHNER BONE WIRES.

Other devices from In2Bones SAS

See all devices from In2Bones SAS →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)