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Orthofix 42-2114

by Avalign Technologies Inc.

Part of a family of 106 devices: see the family page

Ref 42-2114

Orthofix 42-2114 is a Class I device made by Avalign Technologies Inc., registered in EUDAMED on 14 Nov 2025 (Basic UDI-DI 0190776CUTBM) and listed in FDA GUDID since 17 Feb 2023 (UDI-DI 00190776149208), active as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190776CUTBM Basic UDI-DI 00190776149208UDI-DIDate14 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190776149208 UDI-DI Date17 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0190776CUTBM registered 14 Nov 2025 Active
  • FDA GUDID UDI-DI 00190776149208 listed 17 Feb 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00190776149208
  2. Registered EUDAMED 0190776CUTBM

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  • Withdrawn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
Orthofix
Generic name
Orthopaedic osteotome
Device name
Fistula Scissors
Model / reference
42-2114
Primary DI / UDI-DI
00190776149208
Basic UDI-DI
0190776CUTBM
Direct marketing DI
00190776149208
FDA product code
LXH
EMDN code
L090401 Orthopaedic surgery osteotomes, reusable
GMDN term
Orthopaedic osteotome
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic osteotome

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE.

Other devices from Avalign Technologies Inc.

See all devices from Avalign Technologies Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)