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Ortimplant

by Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi 1,000+ variants

Ref O33813524

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

Overview

The Ortimplant medical device is a Class IIb orthopedic implant used for spinal fusion and stabilization, offering unparalleled stability and security. This legacy device has been designed with durability and reliability in mind, ensuring optimal performance over its intended lifespan.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680941123598 Basic UDI-DI 08680941123598UDI-DIDate15 Feb 2024RegisteredStatusActive

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  • Withdrawn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
3,5 Mm Spongioz Ki̇li̇tli̇ Vİda Kismi̇ Yi̇vli̇ Çeli̇k (3,5 Mm Locking Cancellous Screw Partially Threaded Ss) 24 Mm
Model / Reference
O33813524
Primary DI / UDI-DI
08680941123598
Basic UDI-DI
B-08680941123598
EMDN Code
P09120602 Cancellous screws
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017438

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Properties

  • Implantable

Other properties (10)

  • Sterile: No
  • 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