Talon™ DistalFix™ A/R Femoral Nail ART-11-400

GUDID B058ART114001

Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 400mm

Orthopedic Designs North America, Inc.

Femur nail, sterile

• Primary Device ID: B058ART114001
• NIH Device Record Key: 452f078b-f2d3-4eaf-8d0a-ce5b573ff3a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Talon™ DistalFix™ A/R Femoral Nail
• Version Model Number: ART11400
• Catalog Number: ART-11-400
• 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
• 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
• 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: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 400 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058ART114001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152295

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

[B058ART114001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-07
• Device Publish Date: 2021-11-29

On-Brand Devices [Talon™ DistalFix™ A/R Femoral Nail]

• B058ART124201: Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 420mm
• B058ART124001: Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 400mm
• B058ART123801: Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 380mm
• B058ART123601: Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 360mm
• B058ART123401: Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 340mm
• B058ART123201: Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 320mm
• B058ART114201: Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 420mm
• B058ART114001: Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 400mm
• B058ART113801: Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 380mm
• B058ART113601: Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 360mm
• B058ART113401: Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 340mm
• B058ART113201: Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 320mm