Talon™ DistalFix™ End Cap

GUDID B058SLN1550001

Talon™ DistalFix™ End Cap 15.5mm x Flush

Orthopedic Designs North America, Inc.

Bone nail end-cap, sterile

• Primary Device ID: B058SLN1550001
• NIH Device Record Key: 102f7069-de18-497a-b5d3-5a3c7f0c53f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Talon™ DistalFix™ End Cap
• Version Model Number: SLN155000
• 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: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter
• Length: 0 Millimeter
• Outer Diameter: 15.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058SLN1550001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111352

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

[B058SLN1550001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2015-10-19

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

• B058SLN1550101: Talon™ DistalFix™ End Cap 15.5mm x 10mm
• B058SLN1550051: Talon™ DistalFix™ End Cap 15.5mm x 5mm
• B058SLN1550001: Talon™ DistalFix™ End Cap 15.5mm x Flush