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Ortoknee

by Ortonom Medi̇kal Ürünleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 109 variants

Ref DZ00159Model High Cross-Linked Polyethylene Rotation Insert

Active European Union

CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682076500947 Basic UDI-DIDate15 Oct 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
OrtoKnee High Cross-Linked Polyethylene Rotation Insert (CR) Size 2 /18mm
Model / Reference
High Cross-Linked Polyethylene Rotation Insert, DZ00159
Primary DI / UDI-DI
08682076500947
Basic UDI-DI
B-08682076500947
EMDN Code
P090903020201 Bicompartmental primary implant mobile bearing tibial inserts
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

  • Sterile
  • Implantable

Other properties (9)

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