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5400750000

by Stryker Corp.

Ref 5400-750-000Model 08858251003756TP

5400750000 is a device classified as Class IIa in the EU and Class I in the US made by Stryker Corp., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 08858251003756TP) and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 04546540604156), active as of 7 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003756TP Basic UDI-DI 04546540604156UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540604156 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251003756TP registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 04546540604156 listed 24 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540604156
  2. Registered EUDAMED 08858251003756TP

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  • Withdrawn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

Generic name
Surgical power tool system control unit, line-powered
Device name
Bone Mill System
Model / Ref / Catalog
08858251003756TP EUDAMED
5400-750-000 EUDAMED
5400750000 GUDID
Primary DI / UDI-DI
04546540604156
Basic UDI-DI
08858251003756TP
Direct marketing DI
04546540604156
FDA product code
HWE
EMDN code
Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
GMDN term
Surgical power tool system control unit, line-powered
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251003756TP
5400-750-000
GUDID
5400750000
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical power tool system control unit, line-powered

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)