Skip to content

AccelFix Lumbar Expandable Cage System (Sterile)

by L&K Biomed 592 variants

Ref 4018-0806S

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800061631128 Basic UDI-DI 08800061631128UDI-DIDate19 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08800061631128 UDI-DI Date16 Oct 2019ListedStatusListed GUDID: in commercial distribution

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 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
AccelFix Lumbar Expandable Cage System (Sterile) EUDAMED
AccelFix Lumbar Expandable Cage System GUDID
Generic Name
Metallic spinal interbody fusion cage
Model / Ref / Catalog
4018-0806S
Primary DI / UDI-DI
08800061631128
Basic UDI-DI
B-08800061631128
510(k) Number
FDA Product Code
MAX
EMDN Code
P09070101 Spinal cages
GMDN Term
Metallic spinal interbody fusion cage
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3080
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000033200
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from L&K Biomed

See all devices from L&K Biomed →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No