Oxford Ankle Fusion Nail(afn) System

FDA UDI

Class II (US FDA UDI)

by Ortho Solutions Holdings Limited

Identity

Trade Name: OXFORD ANKLE FUSION NAIL(AFN) SYSTEM FDA UDI
Generic Name: Bone nail end-cap FDA UDI
Device Name: OXFORD / OXBRIDGE AFN END CAP 10MM DIA 10MM LONG FDA UDI
Model / Reference: OS331102 FDA UDI
Description: OXFORD / OXBRIDGE AFN END CAP 10MM DIA 10MM LONG FDA UDI

Identifiers

Catalog Number: OS331102 FDA UDI
Primary DI / UDI-DI: 05055662917413 FDA UDI
510(k) Number: K121575 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Bone nail end-cap FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone nail end-cap

Oxford Ankle Fusion Nail(afn) System by Ortho Solutions Holdings Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bone nail end-cap.

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PNP Femur — ORTHOPEDIATRICS CORP. · Class II
EXPert Nail — Synthes · Class II

Cleared under the same submission

K121575 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ortho Solutions Holdings Limited

Sources (1)

FDA UDI e57366d4-a580-4259-9cf8-251039763236 36 fields · synced Jun 8, 2026