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Medfix MF260-1000

by Medfix International, LLC

Part of a family of 13 devices: see the family page

Ref MF260-1000Model Distractor Frame

Medfix MF260-1000 is a Class I device made by Medfix International, LLC, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI 081002183DISTRACTORFRAMYX) and listed in FDA GUDID since 3 Apr 2020 (UDI-DI 00810021835853), active as of 7 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081002183DISTRACTORFRAMYX Basic UDI-DI 00810021835853UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810021835853 UDI-DI Date3 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081002183DISTRACTORFRAMYX registered 17 Sep 2026 Active
  • FDA GUDID UDI-DI 00810021835853 listed 3 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810021835853
  2. Registered EUDAMED 081002183DISTRACTORFRAMYX

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  • Withdrawn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
Medfix
Generic name
Orthopaedic surgical distractor, internal
Model / reference
MF260-1000, Distractor Frame
Primary DI / UDI-DI
00810021835853
Basic UDI-DI
081002183DISTRACTORFRAMYX
Direct marketing DI
00810021835853
FDA product code
LXH
EMDN code
L0920 Orthopaedic surgery distractors, reusable
GMDN term
Orthopaedic surgical distractor, internal
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic surgical distractor, internal

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY DISTRACTORS, REUSABLE.

Other devices from Medfix International, LLC

See all devices from Medfix International, LLC →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)