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Xpert Wrist KIT-WR2D

by Newclip Technics

Part of a family of 52 devices: see the family page

Ref KIT-WR2D

Xpert Wrist KIT-WR2D is a device classified as Class IIb in the EU and Class II in the US made by Newclip Technics, registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 3700569600148T), cleared under FDA 510(k) K213214 on 24 Nov 2021 and listed in FDA GUDID since 14 Nov 2024 (UDI-DI 03700569664879), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 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) K213214

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/MDR EUDAMED Number3700569600148T Basic UDI-DI 03700569664879UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700569664879 UDI-DI Date14 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213214 Date24 Nov 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3700569600148T registered 15 Jul 2026 Active
  • FDA 510(k) K213214 decided 24 Nov 2021 Active
  • FDA GUDID UDI-DI 03700569664879 listed 14 Nov 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213214
  2. Listed FDA GUDID 03700569664879
  3. Registered EUDAMED 3700569600148T

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Xpert Wrist
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Initial R Xpert
Model / Ref / Catalog
KIT-WR2D
Primary DI / UDI-DI
03700569664879
Basic UDI-DI
3700569600148T
510(k) Number
FDA product code
HRS
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

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 fixation plate, non-bioabsorbable

Cleared under the same submission (K213214)

and 8 more cleared under K213214

Similar devices in this category

Other devices filed under BONE FIXATION PLATES - OTHER.

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Properties

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