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Flex Shoulder System MWF721

by Tornier, Inc.

Ref MWF721Model 370038690021EWC

Flex Shoulder System MWF721 is a device classified as Class I in the EU and Class II in the US made by Tornier, Inc., registered in EUDAMED on 7 Aug 2026 (Basic UDI-DI 370038690021EWC), granted FDA De Novo DEN220012 on 16 Dec 2022 and listed in FDA GUDID since 6 Jan 2023 (UDI-DI 03700386957888), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR De Novo

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

De Novo DEN220012

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number370038690021EWC Basic UDI-DI 03700386957888UDI-DIDate7 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386957888 UDI-DI Date6 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG GUDID from GUDID De Novo granted · Post-NSE NumberDEN220012 Date16 Dec 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 370038690021EWC registered 7 Aug 2026 Active
  • FDA De Novo DEN220012 decided 16 Dec 2022 Active
  • FDA GUDID UDI-DI 03700386957888 listed 6 Jan 2023 Listed

Timeline

3 dated events

  1. Granted FDA De Novo DEN220012
  2. Listed FDA GUDID 03700386957888
  3. Registered EUDAMED 370038690021EWC

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA De Novo Active

Specification

EUDAMED · GUDID

Trade name
Flex Shoulder System
Generic name
Orthopaedic implant impactor, reusable
Device name
Tornier Pyrocarbon Humeral Head Instrumentation - Impact Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
MWF721, 370038690021EWC
Primary DI / UDI-DI
03700386957888
Basic UDI-DI
370038690021EWC
Direct marketing DI
03700386957888
De Novo Number
FDA product code
QKW
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Orthopaedic implant impactor, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3695
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic implant impactor, reusable

Cleared under the same submission (DEN220012)

and 8 more cleared under DEN220012

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
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)