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Mj-Flex 1

by Orthofix SRL 18 variants

Part of a family of 181 devices: see the family page

Ref 166300Model ORTHOPEDIC INSTRUMENTS

Mj-Flex 1 (166300) is a manual orthopaedic bender (EU MDR Class I; FDA Class II; FDA product code HTY, Pin, Fixation, Smooth) made by Orthofix SRL, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 805050436Instrum1NASW), cleared under FDA 510(k) K173051 on 16 Nov 2017 and listed in FDA GUDID since 10 Apr 2018 (UDI-DI 18054242518730), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173051

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436Instrum1NASW Basic UDI-DI 18054242518730UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18054242518730 UDI-DI Date10 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173051 Date16 Nov 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805050436Instrum1NASW registered 22 Oct 2026 Active
  • FDA 510(k) K173051 decided 16 Nov 2017 Active
  • FDA GUDID UDI-DI 18054242518730 listed 10 Apr 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173051
  2. Listed FDA GUDID 18054242518730
  3. Registered EUDAMED 805050436Instrum1NASW

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Mj-Flex
Generic name
Manual orthopaedic bender, reusable
Model / Ref / Catalog
ORTHOPEDIC INSTRUMENTS, 166300, 1
Primary DI / UDI-DI
18054242518730
Basic UDI-DI
805050436Instrum1NASW
510(k) Number
FDA product code
HTY
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
Manual orthopaedic bender, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ORTHOPEDIC INSTRUMENTS
166300
GUDID
1
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Manual orthopaedic bender, reusable

Cleared under the same submission (K173051)

and 7 more cleared under K173051

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER.

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)