Skip to content

Ortoknee

by Ortonom Medi̇kal Ürünleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED

Ref DZ00042Model FIX TIBIAL Component Cemented

EMDN P090903020104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682076500275 Basic UDI-DIDate15 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Ortoknee CoCr FIX TIBIAL Component Cemented Size 4 - 68mm
Model / Reference
FIX TIBIAL Component Cemented, DZ00042
Primary DI / UDI-DI
08682076500275
Basic UDI-DI
B-08682076500275
EMDN Code
P090903020104 Bicompartmental primary implant cemented fixed bearing tibial plates
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026671

Other devices from Ortonom Medi̇kal Ürünleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Ortonom Medi̇kal Ürünleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • Incorporates Medicinal Product
Other properties (8)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No

Sources (1)

  • EUDAMED 6f068eb9-3c07-4d05-b38a-5cc77339c63a 61 fields · synced 24 Oct 2026