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Cervical Artificial Discs

by Globus Medical, Inc. United States EUDAMED

Ref 383.105S

EMDN P090799

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0193982CERVICALDISCGH Basic UDI-DIDate20 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000315038 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0297
    Issued
    10 Jun 2026
    Expires
    9 Jun 2031
  • 1000315034 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    10 Jun 2026
    Expires
    14 May 2029
    Reason
    Add device or group

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
383.105S
Primary DI / UDI-DI
00889095226997
Basic UDI-DI
0193982CERVICALDISCGH
Direct Marketing DI
00889095226997
EMDN Code
P090799 Spinal prostheses and stabilisation systems - other
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000019246
Authorised representative
AJW Technology Consulting GmbH DE-AR-000004999

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • 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

Sources (1)

  • EUDAMED 00889095226997|0193982CERVICALDISCGH 61 fields · synced 25 Oct 2026