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: Bone nail end-cap FDA UDI
Device Name: TITANIUM LOW PROFILE SCREW, D 5MM L 80MM FDA UDI
Model / Reference: 1 FDA UDI
Description: TITANIUM LOW PROFILE SCREW, D 5MM L 80MM FDA UDI

Identifiers

Catalog Number: 99-T774080 FDA UDI
Primary DI / UDI-DI: 18033509858574 FDA UDI
FDA Product Code: JDS FDA UDI
HSB FDA UDI
GMDN Term: Bone nail end-cap 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

Yes

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: Length — 80 Millimeter FDA UDI
Outer Diameter — 5 Millimeter FDA UDI

Category: Bone nail end-cap

Ankle Compression Nailing System by Orthofix, Inc. — 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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AJAX Nail — Auxein Medical Private Limited · Class II
PEDIATRIC LOCKING NAIL SYSTEM — Biomet Orthopedics, Inc. · Class II
PNP Femur — ORTHOPEDIATRICS CORP. · Class II
PNP Femur — ORTHOPEDIATRICS CORP. · Class II
EXPert Nail — Synthes · Class II

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 6f44b656-d671-4d05-b358-f0ab83510fe1 36 fields · synced May 30, 2026