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Oxford Ankle Fusion Nail(Afn) System OS330090

by Ortho Solutions Holdings Limited

Ref OS330090Model Oxbridge™ AFN

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number50556629087M Basic UDI-DI 05055662909944UDI-DIDate20 Aug 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number05055662909944 UDI-DI Date20 Mar 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-2780-2017 FDA Class II initiated 19 Apr 2017

    There is a material mislabeling of the AFN End Cap.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Oxford Ankle Fusion Nail(Afn) System
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile
Device Name
Oxbridge™ Implants
Model / Ref / Catalog
OS330090, Oxbridge™ AFN
Primary DI / UDI-DI
05055662909944
Basic UDI-DI
50556629087M
510(k) Number
FDA Product Code
HSB
EMDN Code
P09120601 Cortical screws
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K121575)

Show all (12)

Other devices from Ortho Solutions Holdings Limited

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Properties

  • Sterile
  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No