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Invision IB600001

by Wright Medical Technology, Inc.

Ref IB600001Model 08858251006530TG

Invision IB600001 is a Class I device made by Wright Medical Technology, Inc., registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI 08858251006530TG) and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 00889797049375), 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 Number08858251006530TG Basic UDI-DI 00889797049375UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889797049375 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006530TG registered 12 Oct 2026 Active
  • FDA GUDID UDI-DI 00889797049375 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889797049375
  2. Registered EUDAMED 08858251006530TG

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  • Withdrawn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
Invision® EUDAMED
Invision GUDID
Generic name
Orthopaedic implant aiming/guiding block, reusable
Device name
Invision Total Ankle Revision Instruments - Targeting Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
IB600001, 08858251006530TG
Primary DI / UDI-DI
00889797049375
Basic UDI-DI
08858251006530TG
Direct marketing DI
00889797049375
FDA product code
LXH
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Orthopaedic implant aiming/guiding block, 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: Orthopaedic implant aiming/guiding block, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

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