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MatrixORTHOGNATHIC LOCK

by Synthes GmbH 18 variants

Ref 03.511.415Model Craniomaxillofacial Bending Templates and Sizers

Active European Union

CE MDR

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 22 Oct 2026. What this means

Overview

The MatrixORTHOGNATHIC LOCK (MQ-000013345) is a medical device designed for the placement of craniomaxillofacial bending templates and sizers. This innovative tool enables precise adjustments to the patient's anatomy, providing optimal outcomes in orthodontic treatments.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611819a00070J5 Basic UDI-DI 07611819507609UDI-DIDate30 Jul 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
Craniomaxillofacial Bending Templates and Sizers, 03.511.415
Primary DI / UDI-DI
07611819507609
Basic UDI-DI
7611819a00070J5
Direct Marketing DI
07611819507609
EMDN Code
Z12139099 Various orthopaedic and traumatology instruments - other
Device Class
Class IIa
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CH-MF-000013345
Authorised representative
DePuy Ireland UC IE-AR-000009328

Related devices

Category: Orthopaedic guidewire, reusable

Other devices from Synthes GmbH

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: 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