Talon™ DistalFix™ HTN End Cap Locking HTN-10-C15-L

GUDID B058HTN10C15L1

Talon™ DistalFix™ HTN End Cap Locking 10mm x 15mm

Orthopedic Designs North America, Inc.

Bone nail end-cap, sterile

• Primary Device ID: B058HTN10C15L1
• NIH Device Record Key: 3463189b-b87b-4d9d-8d02-5182d8f66497
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Talon™ DistalFix™ HTN End Cap Locking
• Version Model Number: HTN10C15L
• Catalog Number: HTN-10-C15-L
• 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: false
• 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

Device Dimensions

• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058HTN10C15L1 [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

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

[B058HTN10C15L1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-15
• Device Publish Date: 2019-03-07

On-Brand Devices [Talon™ DistalFix™ HTN End Cap Locking]

• B058HTN10C15L1: Talon™ DistalFix™ HTN End Cap Locking 10mm x 15mm
• B058HTN10C10L1: Talon™ DistalFix™ HTN End Cap Locking 10mm x 10mm
• B058HTN10C05L1: Talon™ DistalFix™ HTN End Cap Locking 10mm x 5mm
• B058HTN10C01L1: Talon™ DistalFix™ HTN End Cap Locking 10mm x Flush