ODI Talon™ Intramedullary Hip Nail

GUDID B058THN125340L1

Proximal Femoral Nail, 125 Degrees - 340mm Long: Left (11mm Distal Diameter)

Orthopedic Designs North America, Inc.

Femur nail, non-sterile

• Primary Device ID: B058THN125340L1
• NIH Device Record Key: 5739d645-3105-4ff2-94c1-d0daa5ead2a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ODI Talon™ Intramedullary Hip Nail
• Version Model Number: THN125340L
• 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
• 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
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 340 Millimeter
• Outer Diameter: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058THN125340L1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033286

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

Moist Heat or Steam Sterilization

[B058THN125340L1]

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: 2015-10-22

On-Brand Devices [ODI Talon™ Intramedullary Hip Nail]

• B058THN135380R1: Proximal Femoral Nail, 135 Degrees - 380mm Long: Right (11mm Distal Diameter)
• B058THN135380L1: Proximal Femoral Nail, 135 Degrees - 380mm Long: Left (11mm Distal Diameter)
• B058THN135340R1: Proximal Femoral Nail, 135 Degrees - 340mm Long: Right (11mm Distal Diameter)
• B058THN135340L1: Proximal Femoral Nail, 135 Degrees - 340mm Long: Left (11mm Distal Diameter)
• B058THN1352101: Proximal Femoral Nail, 135 degree - 210mm (11mm Distal Diameter)
• B058THN130380R1: Proximal Femoral Nail, 130 Degrees - 380mm Long: Right (11mm Distal Diameter)
• B058THN130380L1: Proximal Femoral Nail, 130 Degrees - 380mm Long: Left (11mm Distal Diameter)
• B058THN130340R1: Proximal Femoral Nail, 130 Degrees - 340mm Long: Right (11mm Distal Diameter)
• B058THN130340L1: Proximal Femoral Nail, 130 Degrees - 340mm Long: Left (11mm Distal Diameter)
• B058THN1302101: Proximal Femoral Nail, 130 degree - 210mm (11mm Distal Diameter)
• B058THN125380R1: Proximal Femoral Nail, 125 Degrees - 380mm Long: Right (11mm Distal Diameter)
• B058THN125380L1: Proximal Femoral Nail, 125 Degrees - 380mm Long: Left (11mm Distal Diameter)
• B058THN125340R1: Proximal Femoral Nail, 125 Degrees - 340mm Long: Right (11mm Distal Diameter)
• B058THN125340L1: Proximal Femoral Nail, 125 Degrees - 340mm Long: Left (11mm Distal Diameter)
• B058THN1252101: Proximal Femoral Nail, 125 degree - 210mm (11mm Distal Diameter)
• B058THN0011: Lag Sleeve