Talon™ DistalFix™ Lag Screw

GUDID B058SLN0110801

Talon™ DistalFix™ Lag Screw 11mm x 80mm

Orthopedic Designs North America, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: B058SLN0110801
• NIH Device Record Key: 638957b1-60c9-4d77-a675-72e86dcd9c14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Talon™ DistalFix™ Lag Screw
• Version Model Number: SLN011080
• 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

Device Dimensions

• Outer Diameter: 11 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 11 Millimeter
• Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058SLN0110801 [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

[B058SLN0110801]

Moist Heat or Steam Sterilization

[B058SLN0110801]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-19

On-Brand Devices [Talon™ DistalFix™ Lag Screw]

• B058SLN0111201: Talon™ DistalFix™ Lag Screw 11mm x 120mm
• B058SLN0111151: Talon™ DistalFix™ Lag Screw 11mm x 115mm
• B058SLN0111101: Talon™ DistalFix™ Lag Screw 11mm x 110mm
• B058SLN0111051: Talon™ DistalFix™ Lag Screw 11mm x 105mm
• B058SLN0111001: Talon™ DistalFix™ Lag Screw 11mm x 100mm
• B058SLN0110951: Talon™ DistalFix™ Lag Screw 11mm x 95mm
• B058SLN0110901: Talon™ DistalFix™ Lag Screw 11mm x 90mm
• B058SLN0110851: Talon™ DistalFix™ Lag Screw 11mm x 85mm
• B058SLN0110801: Talon™ DistalFix™ Lag Screw 11mm x 80mm
• B058SLN0110751: Talon™ DistalFix™ Lag Screw 11mm x 75mm
• B058SLN0110701: Talon™ DistalFix™ Lag Screw 11mm x 70mm