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AccelFix Spinal Fixation System (Sterile)

by L&K Biomed 1,000+ variants

Ref 2510-5540S

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-08806344395039 Basic UDI-DI 08806344395039UDI-DIDate30 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08806344395039 UDI-DI Date30 Jan 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  • Withdrawn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 Spinal Fixation System (Sterile) EUDAMED
LnK/PathLoc-L MIS Spinal System GUDID
Generic Name
Bone-screw internal spinal fixation system rod
Model / Reference
2510-5540S
Primary DI / UDI-DI
08806344395039
Basic UDI-DI
B-08806344395039
510(k) Number
FDA Product Code
NKB
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Bone-screw internal spinal fixation system rod
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070
EU market of registration
Spain
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

Related devices

Category: Spinal bone screw, non-bioabsorbable

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