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Agile Nail 1

by Orthofix, Inc. 141 variants

Ref 183277

Agile Nail 1 (183277) is a device classified as Class I in the EU and Class II in the US made by Orthofix, Inc., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-18054242519034), cleared under FDA 510(k) K172699 on 23 Apr 2018 and listed in FDA GUDID since 8 May 2018 (UDI-DI 18054242519034), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172699

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18054242519034 Basic UDI-DI 18054242519034UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18054242519034 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 B-18054242519034 registered 6 Oct 2026 Active
  • FDA 510(k) K172699 decided 23 Apr 2018 Active
  • FDA GUDID UDI-DI 18054242519034 listed 8 May 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172699
  2. Listed FDA GUDID 18054242519034
  3. Registered EUDAMED B-18054242519034

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  • Withdrawn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
Agile Nail
Generic name
Orthopaedic implant calibration pin
Model / Ref / Catalog
183277, 1
Primary DI / UDI-DI
18054242519034
Basic UDI-DI
B-18054242519034
510(k) Number
FDA product code
HSB
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Orthopaedic implant calibration pin
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3020
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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
183277
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: External orthopaedic fixation system, reusable

Cleared under the same submission (K172699)

and 8 more cleared under K172699

Similar devices in this category

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

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (23, all answered No)