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Nk 2010-15

by aap Implantate AG

Ref NK 2010-15Model K-Wire

Nk 2010-15 is a device classified as Class IIb in the EU and Class II in the US made by aap Implantate AG, registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI B-04042409049309), cleared under FDA 510(k) K131459 on 17 Oct 2013 and listed in FDA GUDID since 18 Aug 2016 (UDI-DI 04042409049309), 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) K131459

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-04042409049309 Basic UDI-DI 04042409049309UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042409049309 UDI-DI Date18 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK131459 Date17 Oct 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042409049309 registered 9 Sep 2026 Active
  • FDA 510(k) K131459 decided 17 Oct 2013 Active
  • FDA GUDID UDI-DI 04042409049309 listed 18 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131459
  2. Listed FDA GUDID 04042409049309
  3. Registered EUDAMED B-04042409049309

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  • Withdrawn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
NK 2010-15, K-Wire
Primary DI / UDI-DI
04042409049309
Basic UDI-DI
B-04042409049309
510(k) Number
FDA product code
HTY
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
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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 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.

Related devices

Category: Orthopaedic bone pin, non-bioabsorbable

Cleared under the same submission (K131459)

and 8 more cleared under K131459

Similar devices in this category

Other devices filed under KIRSCHNER BONE WIRES.

Other devices from aap Implantate AG

See all devices from aap Implantate AG →

Properties

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