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Inbone 200046004

by Wright Medical Technology, Inc.

Ref 200046004Model 08858251006878UT

Inbone 200046004 is a device classified as Class IIa in the EU and Class I in the US made by Wright Medical Technology, Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 08858251006878UT) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00889797030281), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006878UT Basic UDI-DI 00889797030281UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889797030281 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006878UT registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00889797030281 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889797030281
  2. Registered EUDAMED 08858251006878UT

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Inbone® EUDAMED
Inbone GUDID
Generic name
Bone-resection orthopaedic reamer, reusable
Device name
INBONE Total Ankle System Instrumentation - Reaming Instrumentation - Class IIa - Non Sterile
Model / Ref / Catalog
200046004, 08858251006878UT
Primary DI / UDI-DI
00889797030281
Basic UDI-DI
08858251006878UT
FDA product code
HTO
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Bone-resection orthopaedic reamer, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
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 IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bone-resection orthopaedic reamer, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)