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Journey II 74014543

by Smith & Nephew, Inc.

Ref 74014543

Journey II 74014543 is a device classified as Class I in the EU and Class II in the US made by Smith & Nephew, Inc., registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 0885556SN000381M7), cleared under FDA 510(k) K200227 on 4 Jun 2020 and listed in FDA GUDID since 7 Jun 2021 (UDI-DI 00885556744451), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200227

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0885556SN000381M7 Basic UDI-DI 00885556744451UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885556744451 UDI-DI Date7 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200227 Date4 Jun 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0885556SN000381M7 registered 9 Sep 2026 Active
  • FDA 510(k) K200227 decided 4 Jun 2020 Active
  • FDA GUDID UDI-DI 00885556744451 listed 7 Jun 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200227
  2. Listed FDA GUDID 00885556744451
  3. Registered EUDAMED 0885556SN000381M7

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  • Withdrawn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
Journey II
Generic name
Bone-coring punch, reusable
Device name
Memphis Class IR SNOI-TF-028 L090999
Model / Ref / Catalog
74014543
Primary DI / UDI-DI
00885556744451
Basic UDI-DI
0885556SN000381M7
510(k) Number
FDA product code
JWH
EMDN code
L090999 Orthopaedic surgery cutting instruments, reusable - other
GMDN term
Bone-coring punch, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3560
EU registration type
Standard device
EU market of registration
Netherlands
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Bone-coring punch, reusable

Cleared under the same submission (K200227)

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)