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KYRA PediatricReduction Multi-Axial Screw 6.5x35mm

by Tria Spine Medikal A.Ş.

Ref KP-10-6535Model KYRA Pediatric System

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

Discover the KYRA PediatricReduction Multi-Axial Screw 6.5x35mm, a pioneering medical device designed for safe and effective pediatric spinal surgery. Learn about its features, compliance status, and FAQs to ensure you have all the information needed to make an informed decision.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682408122991 Basic UDI-DI 08682408122991UDI-DIDate9 Jun 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  • Withdrawn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

Model / Reference
KYRA Pediatric System, KP-10-6535
Primary DI / UDI-DI
08682408122991
Basic UDI-DI
B-08682408122991
EMDN Code
P09070399 Implantable spinal stabilisation or fixation systems - other
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017385

Other devices from Tria Spine Medikal A.Ş.

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Properties

  • Implantable

Other properties (12)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No