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Ortimplant

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

Ref O100 03 219 0300

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 23 Oct 2026. What this means

Overview

The Ortimplant is a revolutionary medical device designed for orthopedic surgery, offering unparalleled precision and accuracy. Built on the legacy of its predecessor, O100 03 219 0300, this device has undergone rigorous testing to meet the highest standards of safety and efficacy. With its advanced features and capabilities, it's no wonder this device is considered a game-changer in the medical field.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680941130251 Basic UDI-DI 08680941130251UDI-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  • Withdrawn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 Tamami Yi̇vli̇ Spongioz Vİda Çeli̇k (3,5 Mm Full Threaded Cancellous Screw Ss) 30 Mm
Model / Reference
O100 03 219 0300
Primary DI / UDI-DI
08680941130251
Basic UDI-DI
B-08680941130251
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