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LnK Spinal Instrument System LCAA-2008

by L&K Biomed Co., Ltd.

Ref LCAA-2008

LnK Spinal Instrument System LCAA-2008 is a Class I device made by L&K Biomed Co., Ltd., registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-08809986460974) and listed in FDA GUDID since 13 Feb 2025 (UDI-DI 08809986460974), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809986460974 Basic UDI-DI 08809986460974UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809986460974 UDI-DI Date13 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809986460974 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 08809986460974 listed 13 Feb 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809986460974
  2. Registered EUDAMED B-08809986460974

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  • Withdrawn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
LnK Spinal Instrument System
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
ALIF TRIAL 20°(24x32) 8mm
Model / Ref / Catalog
LCAA-2008
Primary DI / UDI-DI
08809986460974
Basic UDI-DI
B-08809986460974
FDA product code
LXH
EMDN code
L0923 Orthopaedics surgical measurers, reusable
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
888.4540
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE.

Other devices from L&K Biomed

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Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
Other properties (20, all answered No)