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MWF533

by Tornier, Inc.

Ref MWF533Model 08858251006487U8

MWF533 is a Class I device made by Tornier, Inc., registered in EUDAMED on 24 Jul 2026 (Basic UDI-DI 08858251006487U8) and listed in FDA GUDID since 9 Aug 2022 (UDI-DI 00846832065448), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006487U8 Basic UDI-DI 00846832065448UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832065448 UDI-DI Date9 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006487U8 registered 24 Jul 2026 Active
  • FDA GUDID UDI-DI 00846832065448 listed 9 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00846832065448
  2. Registered EUDAMED 08858251006487U8

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  • Withdrawn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
Intramedullary Cut Guide
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Intramedullary Cut Guide Instruments - Cutting Guides - Class I - Reusable - Non Sterile
Model / Ref / Catalog
MWF533, 08858251006487U8
Primary DI / UDI-DI
00846832065448
Basic UDI-DI
08858251006487U8
Direct marketing DI
00846832065448
FDA product code
FZX
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
878.4800
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 prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

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