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Tornier Flex MWF621

by Tornier, Inc.

Ref MWF621Model 08858251028009U4

Tornier Flex MWF621 is a bone approximation clamp (EU MDR Class I; FDA Class I; FDA product code HXD, Clamp) made by Tornier, Inc., registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 08858251028009U4) and listed in FDA GUDID since 8 Aug 2022 (UDI-DI 03700386977411), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251028009U4 Basic UDI-DI 03700386977411UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386977411 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028009U4 registered 24 Aug 2026 Active
  • FDA GUDID UDI-DI 03700386977411 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700386977411
  2. Registered EUDAMED 08858251028009U4

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  • Withdrawn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 EUDAMED
Tornier Flex GUDID
Generic name
Bone approximation clamp
Device name
Tornier Flex Shoulder System Instrumentation - Forceps - Class I - Reusable - Non Sterile
Model / Ref / Catalog
MWF621, 08858251028009U4
Primary DI / UDI-DI
03700386977411
Basic UDI-DI
08858251028009U4
FDA product code
HXD
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Bone approximation clamp
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: Bone approximation clamp

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS 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)