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LIGAFIX tibial aiming device-evolution

by S.B.M

Ref LIG9000214Model Aiming device

LIGAFIX tibial aiming device-evolution (LIG9000214) is a Class I device made by S.B.M, registered in EUDAMED on 9 Jul 2026 (Basic UDI-DI 376015400DT2019043VM) and listed in FDA GUDID since 25 Sep 2023 (UDI-DI 03760154003643), active as of 23 Oct 2026.

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

CE MDR

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number376015400DT2019043VM Basic UDI-DI 03760154003643UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760154003643 UDI-DI Date25 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376015400DT2019043VM registered 9 Jul 2026 Active
  • FDA GUDID UDI-DI 03760154003643 listed 25 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760154003643
  2. Registered EUDAMED 376015400DT2019043VM

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Ligafix® EUDAMED
Ligafix GUDID
Generic name
Surgical drill guide, reusable
Device name
Aiming device for ACL reconstruction
Model / Ref / Catalog
Aiming device, LIG9000214, LIGAFIX tibial aiming device-evolution
Primary DI / UDI-DI
03760154003643
Basic UDI-DI
376015400DT2019043VM
FDA product code
LXH
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Surgical drill guide, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Aiming device
LIG9000214
GUDID
LIGAFIX tibial aiming device-evolution

Related devices

Category: Surgical drill guide, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

Other devices from S.B.M

See all devices from S.B.M →

Properties

  • Sterilise before use
  • Reusable
  • Measuring function
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)