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Ankle Compression Nailing System 1

by Orthofix, Inc. 89 variants

Ref 177026Model ORTHOPEDIC INSTRUMENTS

Ankle Compression Nailing System 1 (177026) is a device classified as Class I in the EU and Class II in the US made by Orthofix, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 805050436Instrum1NASW), cleared under FDA 510(k) K141571 on 12 Nov 2014 and listed in FDA GUDID since 18 Apr 2018 (UDI-DI 18033509859144), active as of 7 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K141571

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436Instrum1NASW Basic UDI-DI 18033509859144UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18033509859144 UDI-DI Date18 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK141571 Date12 Nov 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805050436Instrum1NASW registered 22 Oct 2026 Active
  • FDA 510(k) K141571 decided 12 Nov 2014 Active
  • FDA GUDID UDI-DI 18033509859144 listed 18 Apr 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K141571
  2. Listed FDA GUDID 18033509859144
  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  • Withdrawn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
Ankle Compression Nailing System
Generic name
Orthopaedic implant aiming arm
Model / Ref / Catalog
ORTHOPEDIC INSTRUMENTS, 177026, 1
Primary DI / UDI-DI
18033509859144
Basic UDI-DI
805050436Instrum1NASW
510(k) Number
FDA product code
HSB
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN term
Orthopaedic implant aiming arm
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3020
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
177026
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: Orthopaedic implant aiming arm

Cleared under the same submission (K141571)

and 8 more cleared under K141571

Similar devices in this category

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

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

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