Talon™ DistalFix™ Humeral Nail HTN-409-180

GUDID B058HTN4091801

Talon™ DistalFix™ Humeral Nail 4° | Ø9mm | 180mm

Orthopedic Designs North America, Inc.

Humerus nail, sterile

• Primary Device ID: B058HTN4091801
• NIH Device Record Key: 379d23c1-498a-41e6-a165-e86abcec3caa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Talon™ DistalFix™ Humeral Nail
• Version Model Number: HTN409180
• Catalog Number: HTN-409-180
• Company DUNS: 945518848
• Company Name: Orthopedic Designs North America, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com
• Phone: 888-635-8535
• Email: support@odi-na.com

Device Dimensions

• Outer Diameter: 9 Millimeter
• Length: 180 Millimeter
• Angle: 4 degree
• Outer Diameter: 9 Millimeter
• Length: 180 Millimeter
• Angle: 4 degree
• Outer Diameter: 9 Millimeter
• Length: 180 Millimeter
• Angle: 4 degree
• Outer Diameter: 9 Millimeter
• Length: 180 Millimeter
• Angle: 4 degree
• Outer Diameter: 9 Millimeter
• Length: 180 Millimeter
• Angle: 4 degree
• Outer Diameter: 9 Millimeter
• Length: 180 Millimeter
• Angle: 4 degree
• Outer Diameter: 9 Millimeter
• Length: 180 Millimeter
• Angle: 4 degree
• Outer Diameter: 9 Millimeter
• Length: 180 Millimeter
• Angle: 4 degree
• Outer Diameter: 9 Millimeter
• Length: 180 Millimeter
• Angle: 4 degree
• Outer Diameter: 9 Millimeter
• Length: 180 Millimeter
• Angle: 4 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058HTN4091801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173255

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[B058HTN4091801]

Moist Heat or Steam Sterilization

[B058HTN4091801]

Moist Heat or Steam Sterilization

[B058HTN4091801]

Moist Heat or Steam Sterilization

[B058HTN4091801]

Moist Heat or Steam Sterilization

[B058HTN4091801]

Moist Heat or Steam Sterilization

[B058HTN4091801]

Moist Heat or Steam Sterilization

[B058HTN4091801]

Moist Heat or Steam Sterilization

[B058HTN4091801]

Moist Heat or Steam Sterilization

[B058HTN4091801]

Moist Heat or Steam Sterilization

[B058HTN4091801]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-16

On-Brand Devices [Talon™ DistalFix™ Humeral Nail]

• B058HTN4103151: Talon™ DistalFix™ Humeral Nail 4° | Ø10mm | 315mm
• B058HTN4103001: Talon™ DistalFix™ Humeral Nail 4° | Ø10mm | 300mm
• B058HTN4102851: Talon™ DistalFix™ Humeral Nail 4° | Ø10mm | 285mm
• B058HTN4102701: Talon™ DistalFix™ Humeral Nail 4° | Ø10mm | 270mm
• B058HTN4102551: Talon™ DistalFix™ Humeral Nail 4° | Ø10mm | 255mm
• B058HTN4102401: Talon™ DistalFix™ Humeral Nail 4° | Ø10mm | 240mm
• B058HTN4102251: Talon™ DistalFix™ Humeral Nail 4° | Ø10mm | 225mm
• B058HTN4102101: Talon™ DistalFix™ Humeral Nail 4° | Ø10mm | 210mm
• B058HTN4101951: Talon™ DistalFix™ Humeral Nail 4° | Ø10mm | 195mm
• B058HTN4101801: Talon™ DistalFix™ Humeral Nail 4° | Ø10mm | 180mm
• B058HTN4101651: Talon™ DistalFix™ Humeral Nail 4° | Ø10mm | 165mm
• B058HTN4093151: Talon™ DistalFix™ Humeral Nail 4° | Ø9mm | 315mm
• B058HTN4093001: Talon™ DistalFix™ Humeral Nail 4° | Ø9mm | 300mm
• B058HTN4092851: Talon™ DistalFix™ Humeral Nail 4° | Ø9mm | 285mm
• B058HTN4092701: Talon™ DistalFix™ Humeral Nail 4° | Ø9mm | 270mm
• B058HTN4092551: Talon™ DistalFix™ Humeral Nail 4° | Ø9mm | 255mm
• B058HTN4092401: Talon™ DistalFix™ Humeral Nail 4° | Ø9mm | 240mm
• B058HTN4092251: Talon™ DistalFix™ Humeral Nail 4° | Ø9mm | 225mm
• B058HTN4092101: Talon™ DistalFix™ Humeral Nail 4° | Ø9mm | 210mm
• B058HTN4091951: Talon™ DistalFix™ Humeral Nail 4° | Ø9mm | 195mm
• B058HTN4091801: Talon™ DistalFix™ Humeral Nail 4° | Ø9mm | 180mm
• B058HTN4091651: Talon™ DistalFix™ Humeral Nail 4° | Ø9mm | 165mm
• B058HTN4083151: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 315mm
• B058HTN4083001: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 300mm
• B058HTN4082851: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 285mm
• B058HTN4082701: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 270mm
• B058HTN4082551: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 255mm
• B058HTN4082401: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 240mm
• B058HTN4082251: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 225mm
• B058HTN4082101: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 210mm
• B058HTN4081951: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 195mm
• B058HTN4081801: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 180mm
• B058HTN4081651: Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 165mm