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5150-9-475

by Stryker GmbH

Ref 5150-9-475Model 08858251002934TG

5150-9-475 is a Class I device made by Stryker GmbH, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI 08858251002934TG) and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 07613327079210), active as of 12 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002934TG Basic UDI-DI 07613327079210UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327079210 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002934TG registered 16 Sep 2026 Active
  • FDA GUDID UDI-DI 07613327079210 listed 24 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327079210
  2. Registered EUDAMED 08858251002934TG

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  • Withdrawn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
Triax
Generic name
External orthopaedic fixation system noninvasive component, single-use
Device name
Monotube Triax - Distraction / Retraction Instrumentation - Class I - Non Sterile
Model / Ref / Catalog
5150-9-475, 08858251002934TG
Primary DI / UDI-DI
07613327079210
Basic UDI-DI
08858251002934TG
Direct marketing DI
07613327079210
FDA product code
LXH
EMDN code
P09120499 External bone fixation systems - other
GMDN term
External orthopaedic fixation system noninvasive component, single-use
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: External orthopaedic fixation system, reusable

Similar devices in this category

Other devices filed under EXTERNAL BONE FIXATION SYSTEMS - OTHER.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)