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Instrument

by Howmedica Osteonics Corp. EUDAMED

Active European Union

Ref I-K4121CB01Model 08858250000796SV

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08858250000796SV Basic UDI-DIDate19 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
TF-018 Class I (r) - Positioning
Model / Reference
08858250000796SV, I-K4121CB01
Primary DI / UDI-DI
07613327389913
Basic UDI-DI
08858250000796SV
Direct Marketing DI
07613327389913
EMDN Code
L091106 Instruments for the preparation of tissue implants in orthopaedic and traumatological surgery, reusable
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000001881
Authorised representative
Stryker European Operations Limited IE-AR-000000092

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Properties

  • Reusable
  • CMR Substance

Other properties (11)

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