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Ortoknee

by Ortonom Medi̇kal Ürünleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ EUDAMED 109 variants

Active European Union

Ref DZ00156Model High Cross-Linked Polyethylene Rotation Insert

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682076500916 Basic UDI-DIDate15 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

Türkiye
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

EU market availability

Made available in 1 country, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Türkiye since 20 Mar 2020

Last checked 29 Oct 2026.

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.

Specification

EUDAMED

Device Name
OrtoKnee High Cross-Linked Polyethylene Rotation Insert (CR) Size 2 /12mm
Model / Reference
High Cross-Linked Polyethylene Rotation Insert, DZ00156
Primary DI / UDI-DI
08682076500916
Basic UDI-DI
B-08682076500916
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