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Ortoknee

by Ortonom Medi̇kal Ürünleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED

Ref DZ00031Model ROTATION TIBIAL Component Cemented

EMDN P090903020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682076500213 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 ROTATION TIBIAL Component Cemented Size 3 - 66mm
Model / Reference
ROTATION TIBIAL Component Cemented, DZ00031
Primary DI / UDI-DI
08682076500213
Basic UDI-DI
B-08682076500213
EMDN Code
P090903020101 Bicompartmental primary implant cemented mobile 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 54daf6bc-104a-4f04-afd5-952e6deaff6c 61 fields · synced 24 Oct 2026