Ankle Compression Nailing System

FDA UDI

Class II (US FDA UDI)

by Orthofix, Inc.

Identity

Trade Name: Ankle Compression Nailing System FDA UDI
Generic Name: Orthopaedic reamer guide FDA UDI
Device Name: 3.0MM X 800MM BALL TIP GUIDE WIRE FDA UDI
Model / Reference: 1 FDA UDI
Description: 3.0MM X 800MM BALL TIP GUIDE WIRE FDA UDI

Identifiers

Catalog Number: 99-177281 FDA UDI
Primary DI / UDI-DI: 18033509858888 FDA UDI
FDA Product Code: JDS FDA UDI
HSB FDA UDI
GMDN Term: Orthopaedic reamer guide FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

Yes

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3 Millimeter FDA UDI
Length — 800 Millimeter FDA UDI

Category: Orthopaedic reamer guide

Ankle Compression Nailing System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic reamer guide.

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Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
MAXIM RESECTION DISTAL — Biomet Orthopedics, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I

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: Orthofix, Inc.

Sources (1)

FDA UDI a80e0c55-869b-45a1-8dc7-29af57575003 36 fields · synced Jun 1, 2026