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MWF109

by Tornier, Inc.

Ref MWF109Model 08858251028015TX

MWF109 is a Class I device made by Tornier, Inc., registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 08858251028015TX) and listed in FDA GUDID since 8 Aug 2022 (UDI-DI 03700386974977), 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 Number08858251028015TX Basic UDI-DI 03700386974977UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386974977 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028015TX registered 24 Aug 2026 Active
  • FDA GUDID UDI-DI 03700386974977 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700386974977
  2. Registered EUDAMED 08858251028015TX

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  • Withdrawn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
Tornier Flex Shoulder System
Generic name
Orthopaedic implant driver
Device name
Tornier Flex Shoulder System Instrumentation - Screwdrivers and Tightening Instrument - Class I - Reusable - Non Sterile
Model / Ref / Catalog
MWF109, 08858251028015TX
Primary DI / UDI-DI
03700386974977
Basic UDI-DI
08858251028015TX
Direct marketing DI
03700386974977
FDA product code
HXX
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic implant driver
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
Size
Outer Diameter — 3.5 Millimeter

Related devices

Category: Orthopaedic implant driver

Similar devices in this category

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

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
  • Manufacturing date
Other properties (18, all answered No)