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5150-9-960

by Stryker GmbH

Ref 5150-9-960Model 08858251006502TB

5150-9-960 is a device classified as Class IIb in the EU and Class II in the US made by Stryker GmbH, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 08858251006502TB), cleared under FDA 510(k) K001886 on 12 Jul 2000 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613327093308), active as of 12 Nov 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K001886

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006502TB Basic UDI-DI 07613327093308UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327093308 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK001886 Date12 Jul 2000DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251006502TB registered 6 Nov 2026 Active
  • FDA 510(k) K001886 decided 12 Jul 2000 Active
  • FDA GUDID UDI-DI 07613327093308 listed 24 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K001886
  2. Listed FDA GUDID 07613327093308
  3. Registered EUDAMED 08858251006502TB

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  • Withdrawn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

Generic name
General internal orthopaedic fixation system implantation kit
Device name
Monotube Triax - Procedure Pack - Sterile
Model / Ref / Catalog
5150-9-960, 08858251006502TB
Primary DI / UDI-DI
07613327093308
Basic UDI-DI
08858251006502TB
510(k) Number
FDA product code
JDW
EMDN code
P09120499 External bone fixation systems - other
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
"The Triax Sterile Kit contains implants, external fixation components and instruments that may be used to apply an external fixation frame for temporary fixation of bones and bone fragments."
GUDID distribution status
In Commercial Distribution

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: General internal orthopaedic fixation system implantation kit

Cleared under the same submission (K001886)

and 8 more cleared under K001886

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

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)