Talon™ DistalFix™ ART Cortical Screw ART-5-110NS

GUDID B058ART5110NS1

Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 110mm (non-sterile)

Orthopedic Designs North America, Inc.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: B058ART5110NS1
• NIH Device Record Key: 5c45a8ec-c3b5-4866-8d5d-e3b1a784beda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Talon™ DistalFix™ ART Cortical Screw
• Version Model Number: ART5110NS
• Catalog Number: ART-5-110NS
• 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: false
• 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

Device Dimensions

• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 110 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058ART5110NS1 [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: false

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

[B058ART5110NS1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-26
• Device Publish Date: 2024-07-18

On-Brand Devices [Talon™ DistalFix™ ART Cortical Screw]

• B058ART51201: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 120mm
• B058ART51151: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 115mm
• B058ART51101: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 110mm
• B058ART51051: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 105mm
• B058ART51001: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 100mm
• B058ART50951: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 095mm
• B058ART50901: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 090mm
• B058ART50851: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 085mm
• B058ART50801: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 080mm
• B058ART50751: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 075mm
• B058ART50701: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 070mm
• B058ART50651: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 065mm
• B058ART50601: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 060mm
• B058ART50551: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 055mm
• B058ART50501: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 050mm
• B058ART50451: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 045mm
• B058ART50401: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 040mm
• B058ART50351: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 035mm
• B058ART50301: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 030mm
• B058ART5055NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 055mm (non-sterile)
• B058ART5050NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 050mm (non-sterile)
• B058ART5045NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 045mm (non-sterile)
• B058ART5040NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 040mm (non-sterile)
• B058ART5035NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 035mm (non-sterile)
• B058ART5030NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 030mm (non-sterile)
• B058ART5095NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 095mm (non-sterile)
• B058ART5090NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 090mm (non-sterile)
• B058ART5085NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 085mm (non-sterile)
• B058ART5080NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 080mm (non-sterile)
• B058ART5075NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 075mm (non-sterile)
• B058ART5070NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 070mm (non-sterile)
• B058ART5065NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 065mm (non-sterile)
• B058ART5060NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 060mm (non-sterile)
• B058ART5120NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 120mm (non-sterile)
• B058ART5115NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 115mm (non-sterile)
• B058ART5110NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 110mm (non-sterile)
• B058ART5105NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 105mm (non-sterile)
• B058ART5100NS1: Talon™ DistalFix™ ART Cortical Screw: Ø5mm x 100mm (non-sterile)