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Variax 705569

by Stryker Corp.

Ref 705569Model 08858251004433T3

Variax 705569 is a Class I device made by Stryker Corp., registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI 08858251004433T3) and listed in FDA GUDID since 7 Nov 2022 (UDI-DI 07613327555547), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251004433T3 Basic UDI-DI 07613327555547UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327555547 UDI-DI Date7 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251004433T3 registered 16 Sep 2026 Active
  • FDA GUDID UDI-DI 07613327555547 listed 7 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327555547
  2. Registered EUDAMED 08858251004433T3

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  • Withdrawn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
Variax
Generic name
General internal orthopaedic fixation system implantation kit
Device name
Variax 2 Instruments - Distraction / Retraction Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
705569, 08858251004433T3
Primary DI / UDI-DI
07613327555547
Basic UDI-DI
08858251004433T3
Direct marketing DI
07613327555547
FDA product code
LXH
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
General internal orthopaedic fixation system implantation kit
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: General internal orthopaedic fixation system implantation kit

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)