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Tornier Perform IFX817

by Tornier, Inc.

Part of a family of 7 devices: see the family page

Ref IFX817Model 08858251006441TG

Tornier Perform IFX817 is a Class I device made by Tornier, Inc., registered in EUDAMED on 8 Oct 2026 (Basic UDI-DI 08858251006441TG) and listed in FDA GUDID since 21 Dec 2022 (UDI-DI 00846832087099), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006441TG Basic UDI-DI 00846832087099UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846832087099 UDI-DI Date21 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006441TG registered 8 Oct 2026 Active
  • FDA GUDID UDI-DI 00846832087099 listed 21 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00846832087099
  2. Registered EUDAMED 08858251006441TG

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  • Withdrawn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® Humeral System EUDAMED
Tornier Perform GUDID
Generic name
Orthopaedic implant/instrument dismantling device
Device name
Tornier Perform Humeral System Instruments - Extraction Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
IFX817, 08858251006441TG
Primary DI / UDI-DI
00846832087099
Basic UDI-DI
08858251006441TG
Direct marketing DI
00846832087099
FDA product code
LXH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic implant/instrument dismantling device
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

Related devices

Category: Orthopaedic implant/instrument dismantling device

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
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)