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Mj-Flex 1

by Orthofix SRL 18 variants

Ref 166978

Mj-Flex 1 (166978) is a bone fixation plate pliers insert (EU MDD Class I; FDA Class II; FDA product code HTY, Pin, Fixation, Smooth) made by Orthofix SRL, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-18054242518792), cleared under FDA 510(k) K173051 on 16 Nov 2017 and listed in FDA GUDID since 10 Apr 2018 (UDI-DI 18054242518792), active as of 12 Nov 2026.

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

CE MDD 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/MDD EUDAMED NumberB-18054242518792 Basic UDI-DI 18054242518792UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18054242518792 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 B-18054242518792 registered 6 Oct 2026 Active
  • FDA 510(k) K173051 decided 16 Nov 2017 Active
  • FDA GUDID UDI-DI 18054242518792 listed 10 Apr 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173051
  2. Listed FDA GUDID 18054242518792
  3. Registered EUDAMED B-18054242518792

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Mj-Flex
Generic name
Bone fixation plate pliers insert
Model / Ref / Catalog
166978, 1
Primary DI / UDI-DI
18054242518792
Basic UDI-DI
B-18054242518792
510(k) Number
FDA product code
HTY
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Bone fixation plate pliers insert
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3040
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
166978
GUDID
1
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 18054242518792: EUDAMED states No, FDA GUDID states Yes.

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: Bone fixation plate pliers insert

Cleared under the same submission (K173051)

and 7 more cleared under K173051

Similar devices

Also classified as Bone fixation plate pliers insert.

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

Properties

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