Talon™ DistalFix™ Humeral Nail

FDA UDI

Class II (US FDA UDI)

by Orthopedic Designs North America, Inc.

Identity

Trade Name: Talon™ DistalFix™ Humeral Nail FDA UDI
Generic Name: Humerus intramedullary nail FDA UDI
Device Name: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 165mm FDA UDI
Model / Reference: HTN408165 FDA UDI
Description: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 165mm FDA UDI

Identifiers

Catalog Number: HTN-408-165 FDA UDI
Primary DI / UDI-DI: B058HTN4081651 FDA UDI
510(k) Number: K173255 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Humerus intramedullary nail 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

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

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 8 Millimeter FDA UDI
Length — 165 Millimeter FDA UDI
Angle — 4 degree FDA UDI

Category: Humerus intramedullary nail

Talon™ DistalFix™ Humeral Nail by Orthopedic Designs North America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Humerus intramedullary nail.

TRIGEN — Smith & Nephew, Inc. · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
M/DN® — Zimmer, Inc. · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
MULTILOC — Synthes · Class II
TELEGRAPH® — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
TRIGEN — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K173255 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: Orthopedic Designs North America, Inc.

Sources (1)

FDA UDI 433fd40c-55de-417f-84ad-c8cad5cc7358 37 fields · synced May 30, 2026