Skip to content

5085-1-227

by Stryker GmbH

Ref 5085-1-227Model 08858251003017SA

5085-1-227 is a device classified as Class IIa in the EU and Class I in the US made by Stryker GmbH, registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 08858251003017SA) and listed in FDA GUDID since 7 Apr 2020 (UDI-DI 04546540657435), 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 Number08858251003017SA Basic UDI-DI 04546540657435UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540657435 UDI-DI Date7 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251003017SA registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 04546540657435 listed 7 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540657435
  2. Registered EUDAMED 08858251003017SA

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  • Withdrawn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
Fluted surgical drill bit, single-use
Device name
Generic Instruments - Drilling Instrumentation - Class Iia - Sterile
Model / Ref / Catalog
5085-1-227, 08858251003017SA
Primary DI / UDI-DI
04546540657435
Basic UDI-DI
08858251003017SA
FDA product code
LXH
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Fluted surgical drill bit, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 150.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Fluted surgical drill bit, single-use

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)