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Ankle Compression Nailing System 1

by Orthofix, Inc. 89 variants

Ref 99-T77230

Ankle Compression Nailing System 1 (99-T77230) is a device classified as Class IIb in the EU and Class II in the US made by Orthofix, Inc., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-18054242512981), cleared under FDA 510(k) K141571 on 12 Nov 2014 and listed in FDA GUDID since 8 Jul 2016 (UDI-DI 18054242512981), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K141571

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18054242512981 Basic UDI-DI 18054242512981UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18054242512981 UDI-DI Date8 Jul 2016ListedStatusListed 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 B-18054242512981 registered 6 Oct 2026 Active
  • FDA 510(k) K141571 decided 12 Nov 2014 Active
  • FDA GUDID UDI-DI 18054242512981 listed 8 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K141571
  2. Listed FDA GUDID 18054242512981
  3. Registered EUDAMED B-18054242512981

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  • Withdrawn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
Ankle Hindfoot Nailing System EUDAMED
Ankle Compression Nailing System GUDID
Generic name
Arthrodesis intramedullary nail, non-distracting
Model / Ref / Catalog
99-T77230, 1
Primary DI / UDI-DI
18054242512981
Basic UDI-DI
B-18054242512981
510(k) Number
FDA product code
HSB
EMDN code
P09120201 Intramedullary nails
GMDN term
Arthrodesis intramedullary nail, non-distracting
Device class
Class IIb 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
Size
Length — 300 Millimeter
Outer Diameter — 12 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
99-T77230
GUDID
1
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Arthrodesis intramedullary nail, non-distracting

Cleared under the same submission (K141571)

and 8 more cleared under K141571

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • HCT/P
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)