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Affiniti 9000381

by Tornier, Inc.

Ref 9000381Model 08858251006389U7

Affiniti 9000381 is a Class I device made by Tornier, Inc., registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI 08858251006389U7) and listed in FDA GUDID since 9 Aug 2022 (UDI-DI 00846832021963), 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 Number08858251006389U7 Basic UDI-DI 00846832021963UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832021963 UDI-DI Date9 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006389U7 registered 16 Sep 2026 Active
  • FDA GUDID UDI-DI 00846832021963 listed 9 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00846832021963
  2. Registered EUDAMED 08858251006389U7

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  • Withdrawn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
Affiniti™ EUDAMED
Affiniti GUDID
Generic name
Hand-held surgical retractor, reusable
Device name
Tornier Simpliciti Shoulder System Instruments - Distraction / Retraction Instrument - Class I - Reusable - Non Sterile
Model / Ref / Catalog
9000381, 08858251006389U7
Primary DI / UDI-DI
00846832021963
Basic UDI-DI
08858251006389U7
Direct marketing DI
00846832021963
FDA product code
GAD
EMDN code
L0915 Spreaders and retractors for orthopaedic surgery, reusable
GMDN term
Hand-held surgical retractor, 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: Hand-held surgical retractor, reusable

Similar devices in this category

Other devices filed under SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)