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: Cannulated surgical drill bit, single-use FDA UDI
Device Name: AFN MISS 5MM CANNULATED DRILL FDA UDI
Model / Reference: OS333525 FDA UDI
Description: AFN MISS 5MM CANNULATED DRILL FDA UDI

Identifiers

Catalog Number: OS333525 FDA UDI
Primary DI / UDI-DI: 05055662944785 FDA UDI
510(k) Number: K121575 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Cannulated surgical drill bit, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cannulated surgical drill bit, single-use

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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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 84a7e30e-bb89-4afd-b95d-58227e61d389 36 fields · synced May 30, 2026