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Oxford Ankle Fusion Nail (Afn) System OS333113-S

by Ortho Solutions Holdings Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055662976588 UDI-DI Date11 Sep 2026ListedStatusListed GUDID: in commercial distribution

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

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Oxford Ankle Fusion Nail (Afn) System
Generic Name
Joint prosthesis implantation kit, single-use
Model / Ref / Catalog
OS333113-S
Primary DI / UDI-DI
05055662976588
510(k) Number
FDA Product Code
HSB
GMDN Term
Joint prosthesis implantation kit, single-use
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K121575)

Show all (12)

Other devices from Ortho Solutions Holdings Limited

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No