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3d Lumbar Cage

by FIMS Co., Ltd.

Ref 3d Lumbar CageModel LT(14,11,42,8,0,1.1,0.9,3)

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180347↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800065836642 Basic UDI-DI 08800065836642UDI-DIDate15 Jan 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK180347 Date28 Oct 2019IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Model / Reference
LT(14, 11, 42, 8, 0, 1.1, 0.9, 3), 3d Lumbar Cage
Primary DI / UDI-DI
08800065836642
Basic UDI-DI
B-08800065836642
EMDN Code
P09070101 Spinal cages
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
KR-MF-000030624
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Sterile
  • Implantable

Other properties (9)

  • 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