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Sps 619909

by Stryker GmbH

Ref 619909Model 08858251005706TN

Sps 619909 is a device classified as Class IIb in the EU and Class II in the US made by Stryker GmbH, registered in EUDAMED on 16 Jul 2026 (Basic UDI-DI 08858251005706TN) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 04546540094100), 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 Number08858251005706TN Basic UDI-DI 04546540094100UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540094100 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251005706TN registered 16 Jul 2026 Active
  • FDA GUDID UDI-DI 04546540094100 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540094100
  2. Registered EUDAMED 08858251005706TN

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  • Withdrawn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
Sps™ EUDAMED
Sps GUDID
Generic name
Implantable bone washer
Device name
Sps Screws - Washer - Titanium Alloy - Class Iib - Non Sterile
Model / Ref / Catalog
619909, 08858251005706TN
Primary DI / UDI-DI
04546540094100
Basic UDI-DI
08858251005706TN
FDA product code
HWC, HTN, OUR
EMDN code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN term
Implantable bone washer
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040, 888.3030
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 · 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: Implantable bone washer

Similar devices in this category

Other devices filed under BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)