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Tornier Perform MWH629S

by Tornier, Inc.

Ref MWH629SModel 084683200133DYB

Tornier Perform MWH629S is a Class I device made by Tornier, Inc., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI 084683200133DYB) and listed in FDA GUDID since 9 Aug 2022 (UDI-DI 00846832069750), 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 Number084683200133DYB Basic UDI-DI 00846832069750UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832069750 UDI-DI Date9 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 084683200133DYB registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 00846832069750 listed 9 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00846832069750
  2. Registered EUDAMED 084683200133DYB

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  • Withdrawn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 Perform® Anatomic Augmented Glenoid EUDAMED
Tornier Perform GUDID
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Tornier Perform Anatomic Augmented Glenoid Instruments - Guiding Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
MWH629S, 084683200133DYB
Primary DI / UDI-DI
00846832069750
Basic UDI-DI
084683200133DYB
Direct marketing DI
00846832069750
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
  • Manufacturing date
Other properties (18, all answered No)