ODI Talon™ Intramedullary Hip Nail

FDA UDI

Class II (US FDA UDI)

by Orthopedic Designs North America, Inc.

Identity

Trade Name: ODI Talon™ Intramedullary Hip Nail FDA UDI
Generic Name: Femur intramedullary nail FDA UDI
Device Name: Proximal Femoral Nail, 125 Degrees - 340mm Long: Right (11mm Distal Diameter) FDA UDI
Model / Reference: THN125340R FDA UDI
Description: Proximal Femoral Nail, 125 Degrees - 340mm Long: Right (11mm Distal Diameter) FDA UDI

Identifiers

Primary DI / UDI-DI: B058THN125340R1 FDA UDI
510(k) Number: K033286 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Femur 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

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 11 Millimeter FDA UDI
Length — 340 Millimeter FDA UDI
Angle — 125 degree FDA UDI

Category: Femur intramedullary nail

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

Similar devices

Also classified as Femur intramedullary nail.

GAMMA — Stryker Corp. · Class II
A.R.T.™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
T2 ALPHA — Stryker Corp. · Class II
PRECICE® Bone Transport System — NuVasive Specialized Orthopedics, Inc. · Class II
T2 — Stryker Corp. · Class II
130° Ga-mma Nail — Auxein Medical Private Limited · Class II
ARIX Femur Nail System — Jeil Medical Corporation · Class II
INTERTAN — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K033286 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 8ad5a8af-4570-4d07-b730-89969a53c027 36 fields · synced May 30, 2026