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DENALI® Spinal System

by K2M, Inc. 128 variants

Ref 101-90084Model 08858251001819T8

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08858251001819T8 Basic UDI-DI 10888857471566UDI-DIDate31 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Denali Container
Model / reference
08858251001819T8, 101-90084
Primary DI / UDI-DI
10888857471566
Basic UDI-DI
08858251001819T8
Direct marketing DI
10888857471566
EMDN code
V0402 Clinical use trays and bowls
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000004440
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from K2M, Inc.

See all devices from K2M, Inc. →

Properties

  • Sterilise before use

Other properties (13)

  • Supplied sterile: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No