Skip to content

Ligafix

by S.B.M 13 variants

Ref LIG9008289Model Cutting instrument for ACL reconstruction

Ligafix (LIG9008289) is a cannulated surgical drill bit (EU MDD Class IIa; FDA Class I; FDA product code HTW, Bit, Drill) made by S.B.M, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI B-03760154005777) and listed in FDA GUDID since 25 Sep 2023 (UDI-DI 03760154005777), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760154005777 Basic UDI-DI 03760154005777UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760154005777 UDI-DI Date25 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03760154005777 registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 03760154005777 listed 25 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760154005777
  2. Registered EUDAMED B-03760154005777

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  • Withdrawn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

Generic name
Cannulated surgical drill bit, reusable
Device name
Cutting instrument
Model / Ref / Catalog
Cutting instrument for ACL reconstruction, LIG9008289, LIGAFIX L 60 mm - diameter 8 mm cannulated drill bit, longflute
Primary DI / UDI-DI
03760154005777
Basic UDI-DI
B-03760154005777
FDA product code
HTW
EMDN code
L090999 Orthopaedic surgery cutting instruments, reusable - other
GMDN term
Cannulated surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Cutting instrument for ACL reconstruction
LIG9008289
GUDID
LIGAFIX L 60 mm - diameter 8 mm cannulated drill bit, longflute
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cannulated surgical drill bit, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY CUTTING 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 (17, all answered No)