Skip to content

Ankle Compression Nailing System 1

by Orthofix, Inc. 89 variants

Ref 99-T774080

Ankle Compression Nailing System 1 (99-T774080) 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-18033509858574) and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 18033509858574), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18033509858574 Basic UDI-DI 18033509858574UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18033509858574 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-18033509858574 registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 18033509858574 listed 1 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 18033509858574
  2. Registered EUDAMED B-18033509858574

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Ankle Hindfoot Nailing System EUDAMED
Ankle Compression Nailing System GUDID
Generic name
Bone nail implantable cap
Model / Ref / Catalog
99-T774080, 1
Primary DI / UDI-DI
18033509858574
Basic UDI-DI
B-18033509858574
FDA product code
JDS, HSB
EMDN code
P09120202 Intramedullary nails in complex systems
GMDN term
Bone nail implantable cap
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030, 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 — 80 Millimeter
Outer Diameter — 5 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
99-T774080
GUDID
1
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Bone nail end-cap

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)