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Ankle Compression Nailing System 1

by Orthofix SRL 89 variants

Ref 99-T774045

Ankle Compression Nailing System 1 (99-T774045) is a device classified as Class IIb in the EU and Class II in the US made by Orthofix SRL, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-18033509858505) and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 18033509858505), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18033509858505 Basic UDI-DI 18033509858505UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18033509858505 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-18033509858505 registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 18033509858505 listed 1 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 18033509858505
  2. Registered EUDAMED B-18033509858505

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  • Withdrawn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-T774045, 1
Primary DI / UDI-DI
18033509858505
Basic UDI-DI
B-18033509858505
FDA product code
HSB, JDS
EMDN code
P09120202 Intramedullary nails in complex systems
GMDN term
Bone nail implantable cap
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3020, 888.3030
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
Outer Diameter — 5 Millimeter
Length — 45 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
99-T774045
GUDID
1
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Device class is stated on each registry's own scale: Class IIb 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: Bone nail end-cap

Similar devices in this category

Other devices filed under BONE FIXATION NAILS.

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

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)