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Inbone 200395

by Wright Medical Technology, Inc.

Ref 200395Model 08858251006877UR

Inbone 200395 is a Class I device made by Wright Medical Technology, Inc., registered in EUDAMED on 11 Oct 2026 (Basic UDI-DI 08858251006877UR) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00840420196446), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006877UR Basic UDI-DI 00840420196446UDI-DIDate11 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840420196446 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006877UR registered 11 Oct 2026 Active
  • FDA GUDID UDI-DI 00840420196446 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840420196446
  2. Registered EUDAMED 08858251006877UR

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  • Withdrawn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 I - Reusable - Non Sterile
Model / Ref / Catalog
200395, 08858251006877UR
Primary DI / UDI-DI
00840420196446
Basic UDI-DI
08858251006877UR
Direct marketing DI
00840420196446
FDA product code
HTO
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Bone-resection orthopaedic reamer, reusable
Device class
Class I
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

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
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)