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0206716000

by Stryker Corp.

Ref 0206-716-000Model 08858251002439SZ

0206716000 (0206-716-000) is a device classified as Class IIa in the EU and Class I in the US made by Stryker Corp., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 08858251002439SZ) and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 04546540039668), 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 Number08858251002439SZ Basic UDI-DI 04546540039668UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540039668 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002439SZ registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 04546540039668 listed 24 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540039668
  2. Registered EUDAMED 08858251002439SZ

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  • Withdrawn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
Orthopaedic cement preparation/delivery kit
Device name
Bone Preparation
Model / Ref / Catalog
08858251002439SZ, 0206-716-000, 0206716000
Primary DI / UDI-DI
04546540039668
Basic UDI-DI
08858251002439SZ
FDA product code
LXH
EMDN code
P09088099 Hip prostheses - other accessories
GMDN term
Orthopaedic cement preparation/delivery kit
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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002439SZ
0206-716-000
GUDID
0206716000
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: Orthopaedic cement preparation/delivery kit

Similar devices in this category

Other devices filed under HIP PROSTHESES - OTHER ACCESSORIES.

Other devices from Stryker Corp.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)