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LIGAFIX Non-cannulated drill bit

by S.B.M

Ref LIG9045FORModel Cutting instrument for ACL reconstruction

LIGAFIX Non-cannulated drill bit (LIG9045FOR) 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 21 Sep 2026 (Basic UDI-DI B-03760154002332) and listed in FDA GUDID since 20 Dec 2023 (UDI-DI 03760154002332), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760154002332 Basic UDI-DI 03760154002332UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760154002332 UDI-DI Date20 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03760154002332 registered 21 Sep 2026 Active
  • FDA GUDID UDI-DI 03760154002332 listed 20 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760154002332
  2. Registered EUDAMED B-03760154002332

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  • Withdrawn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
Ligafix
Generic name
Cannulated surgical drill bit, reusable
Device name
Cutting instrument
Model / Ref / Catalog
Cutting instrument for ACL reconstruction, LIG9045FOR, Non-cannulated drill bit
Primary DI / UDI-DI
03760154002332
Basic UDI-DI
B-03760154002332
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
Size
Outer Diameter — 4.5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Cutting instrument for ACL reconstruction
LIG9045FOR
GUDID
Non-cannulated drill bit
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)