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Agile Nail 1

by Orthofix, Inc. 141 variants

Ref 183100Model VARIOUS ORTHOPEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHERS Instrumentation for insertion and extraction of intramedullary nails

Agile Nail 1 (183100) is a device classified as Class IIa in the EU and Class II in the US made by Orthofix, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 805050436NStInsNail2a25E7), cleared under FDA 510(k) K172699 on 23 Apr 2018 and listed in FDA GUDID since 8 May 2018 (UDI-DI 18054242518990), 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) K172699

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 Number805050436NStInsNail2a25E7 Basic UDI-DI 18054242518990UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18054242518990 UDI-DI Date8 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172699 Date23 Apr 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805050436NStInsNail2a25E7 registered 22 Oct 2026 Active
  • FDA 510(k) K172699 decided 23 Apr 2018 Active
  • FDA GUDID UDI-DI 18054242518990 listed 8 May 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172699
  2. Listed FDA GUDID 18054242518990
  3. Registered EUDAMED 805050436NStInsNail2a25E7

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  • Withdrawn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
Orthofix Surgical Instruments EUDAMED
Agile Nail GUDID
Generic name
Orthopaedic implant aiming arm
Model / Ref / Catalog
VARIOUS ORTHOPEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHERS Instrumentation for insertion and extraction of intramedullary nails, 183100, 1
Primary DI / UDI-DI
18054242518990
Basic UDI-DI
805050436NStInsNail2a25E7
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 IIa 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
Size
Width — 14 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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 (K172699)

and 8 more cleared under K172699

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS.

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)