Talon™ DistalFix™ Proximal Femoral Nail

GUDID B058SLN12530L1

Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 300mm, Left

Orthopedic Designs North America, Inc.

Femur nail, sterile

• Primary Device ID: B058SLN12530L1
• NIH Device Record Key: 42c2f11a-b269-4e18-96a2-ca2ab69e6e32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Talon™ DistalFix™ Proximal Femoral Nail
• Version Model Number: SLN12530L
• 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

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Length: 300 Millimeter
• Angle: 125 degree
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Length: 300 Millimeter
• Angle: 125 degree
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Length: 300 Millimeter
• Angle: 125 degree
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Length: 300 Millimeter
• Angle: 125 degree
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Length: 300 Millimeter
• Angle: 125 degree
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Length: 300 Millimeter
• Angle: 125 degree
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Length: 300 Millimeter
• Angle: 125 degree
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Length: 300 Millimeter
• Angle: 125 degree
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Length: 300 Millimeter
• Angle: 125 degree
• Device Size Text, specify: 0
• Outer Diameter: 11 Millimeter
• Length: 300 Millimeter
• Angle: 125 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058SLN12530L1 [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

[B058SLN12530L1]

Moist Heat or Steam Sterilization

[B058SLN12530L1]

Moist Heat or Steam Sterilization

[B058SLN12530L1]

Moist Heat or Steam Sterilization

[B058SLN12530L1]

Moist Heat or Steam Sterilization

[B058SLN12530L1]

Moist Heat or Steam Sterilization

[B058SLN12530L1]

Moist Heat or Steam Sterilization

[B058SLN12530L1]

Moist Heat or Steam Sterilization

[B058SLN12530L1]

Moist Heat or Steam Sterilization

[B058SLN12530L1]

Moist Heat or Steam Sterilization

[B058SLN12530L1]

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™ Proximal Femoral Nail]

• B058SLN1302201: Talon™ DistalFix™ Proximal Femoral Nail 130 Degree x 220mm, Universal
• B058SLN12542R1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 420mm, Right
• B058SLN12542L1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 420mm, Left
• B058SLN12540R1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 400mm, Right
• B058SLN12540L1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 400mm, Left
• B058SLN12538R1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 380mm, Right
• B058SLN12538L1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 380mm, Left
• B058SLN12536R1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 360mm, Right
• B058SLN12536L1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 360mm, Left
• B058SLN12534R1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 340mm, Right
• B058SLN12534L1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 340mm, Left
• B058SLN12532R1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 320mm, Right
• B058SLN12532L1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 320mm, Left
• B058SLN12530R1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 300mm, Right
• B058SLN12530L1: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 300mm, Left
• B058SLN1252201: Talon™ DistalFix™ Proximal Femoral Nail 125 Degree x 220mm, Universal
• B058SLN1202201: Talon™ DistalFix™ Proximal Femoral Nail 120 Degree x 220mm, Universal