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Ligafix

by S.B.M 13 variants

Ref LIG9010B45Model Aiming device

Ligafix (LIG9010B45) is a surgical drill guide (EU MDR Class I; FDA Class I; FDA product code LXH, Orthopedic Manual Surgical Instrument) made by S.B.M, registered in EUDAMED on 20 Oct 2023 (Basic UDI-DI 376015400DT2019048VX) and listed in FDA GUDID since 25 Sep 2023 (UDI-DI 03760154003971), 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 Number376015400DT2019048VX Basic UDI-DI 03760154003971UDI-DIDate20 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number03760154003971 UDI-DI Date25 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376015400DT2019048VX registered 20 Oct 2023 Active
  • FDA GUDID UDI-DI 03760154003971 listed 25 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760154003971
  2. Registered EUDAMED 376015400DT2019048VX

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  • Withdrawn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

Generic name
Surgical drill guide, reusable
Device name
Aiming device for ACL reconstruction
Model / Ref / Catalog
Aiming device, LIG9010B45, Pistol-grip femoral aiming device Ø 10 mm
Primary DI / UDI-DI
03760154003971
Basic UDI-DI
376015400DT2019048VX
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
Türkiye
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
LIG9010B45
GUDID
Pistol-grip femoral aiming device Ø 10 mm

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
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)