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Sps™

by Stryker GmbH 478 variants

Ref 340630SModel 08858251006778UN

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08858251006778UN Basic UDI-DI 04546540416674UDI-DIDate16 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sps Screws - Screw - Stainless Steel - Class Iib - Sterile
Model / Reference
08858251006778UN, 340630S
Primary DI / UDI-DI
04546540416674
Basic UDI-DI
08858251006778UN
EMDN Code
P09120601 Cortical screws
Device Class
Class IIb
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CH-MF-000009332
Authorised representative
Stryker European Operations Limited IE-AR-000000092

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterile
  • Implantable
  • Sutures

Other properties (11)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No