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Variax 625108

by Stryker Corp.

Ref 625108Model 08858251005668U7

Variax 625108 is a device classified as Class IIb in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 28 Jul 2026 (Basic UDI-DI 08858251005668U7), cleared under FDA 510(k) K212581 on 19 Jan 2022 and listed in FDA GUDID since 27 Apr 2022 (UDI-DI 07613327348118), active as of 23 Oct 2026.

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

CE MDR 510(k)

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

510(k) K212581

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 Number08858251005668U7 Basic UDI-DI 07613327348118UDI-DIDate28 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327348118 UDI-DI Date27 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212581 Date19 Jan 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251005668U7 registered 28 Jul 2026 Active
  • FDA 510(k) K212581 decided 19 Jan 2022 Active
  • FDA GUDID UDI-DI 07613327348118 listed 27 Apr 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212581
  2. Listed FDA GUDID 07613327348118
  3. Registered EUDAMED 08858251005668U7

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
VariAx®2 DR EUDAMED
Variax GUDID
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Variax 2 Distal Radius and Variax 2 Distal Ulna - Plate - Titanium Alloy - Class Iib - Non-Sterile
Model / Ref / Catalog
625108, 08858251005668U7
Primary DI / UDI-DI
07613327348118
Basic UDI-DI
08858251005668U7
510(k) Number
FDA product code
HRS
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional
Size
Length — 198.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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 fixation plate, non-bioabsorbable

Cleared under the same submission (K212581)

and 8 more cleared under K212581

Similar devices in this category

Other devices filed under BONE FIXATION PLATES - OTHER.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)