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Core 5400010056

by Stryker Corp.

Ref 5400-010-056Model 08858251004439TF

Core 5400010056 (5400-010-056) is a device classified as Class IIa in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 08858251004439TF) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07613153009207), 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 Number08858251004439TF Basic UDI-DI 07613153009207UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613153009207 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251004439TF registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 07613153009207 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613153009207
  2. Registered EUDAMED 08858251004439TF

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  • Withdrawn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
Core
Generic name
Drilling power tool attachment, basic
Device name
Small Bone Attachments
Model / Ref / Catalog
08858251004439TF, 5400-010-056, 5400010056
Primary DI / UDI-DI
07613153009207
Basic UDI-DI
08858251004439TF
Direct marketing DI
07613153009207
FDA product code
HBB
EMDN code
Z12130503 Orthopaedic surgical drills
GMDN term
Drilling power tool attachment, basic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4370
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251004439TF
5400-010-056
GUDID
5400010056
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Drilling power tool attachment, basic

Similar devices

Also classified as Drilling power tool attachment, basic.

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGICAL DRILLS.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)