Atlas™ Humeral Nail System AS-5-064

GUDID B058AS50641

Atlas Humeral Nail System - Atlas Screw Ø5mm x 064mm

Orthopedic Designs North America, Inc.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: B058AS50641
• NIH Device Record Key: 65583d88-396b-4ad7-b595-33a749af7a36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atlas™ Humeral Nail System
• Version Model Number: AS5064
• Catalog Number: AS-5-064
• 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

Device Dimensions

• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 64 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058AS50641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241484

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[B058AS50641]

Moist Heat or Steam Sterilization

[B058AS50641]

Moist Heat or Steam Sterilization

[B058AS50641]

Moist Heat or Steam Sterilization

[B058AS50641]

Moist Heat or Steam Sterilization

[B058AS50641]

Moist Heat or Steam Sterilization

[B058AS50641]

Moist Heat or Steam Sterilization

[B058AS50641]

Moist Heat or Steam Sterilization

[B058AS50641]

Moist Heat or Steam Sterilization

[B058AS50641]

Moist Heat or Steam Sterilization

[B058AS50641]

Moist Heat or Steam Sterilization

[B058AS50641]

Moist Heat or Steam Sterilization

[B058AS50641]

Moist Heat or Steam Sterilization

[B058AS50641]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-22
• Device Publish Date: 2025-01-14

On-Brand Devices [Atlas™ Humeral Nail System]

• B058AS50681: Atlas Humeral Nail System - Atlas Screw Ø5mm x 068mm
• B058AS50641: Atlas Humeral Nail System - Atlas Screw Ø5mm x 064mm
• B058AS50601: Atlas Humeral Nail System - Atlas Screw Ø5mm x 060mm
• B058AS50561: Atlas Humeral Nail System - Atlas Screw Ø5mm x 056mm
• B058AS50521: Atlas Humeral Nail System - Atlas Screw Ø5mm x 052mm
• B058AS50481: Atlas Humeral Nail System - Atlas Screw Ø5mm x 048mm
• B058AS50461: Atlas Humeral Nail System - Atlas Screw Ø5mm x 046mm
• B058AS50441: Atlas Humeral Nail System - Atlas Screw Ø5mm x 044mm
• B058AS50421: Atlas Humeral Nail System - Atlas Screw Ø5mm x 042mm
• B058AS50401: Atlas Humeral Nail System - Atlas Screw Ø5mm x 040mm
• B058AHN08240R1: Atlas Humeral Nail System - Nail Ø8mm | 240mm | Right
• B058AHN08240L1: Atlas Humeral Nail System - Nail Ø8mm | 240mm | Left
• B058AHN08225R1: Atlas Humeral Nail System - Nail Ø8mm | 225mm | Right
• B058AHN08225L1: Atlas Humeral Nail System - Nail Ø8mm | 225mm | Left
• B058AHN08210R1: Atlas Humeral Nail System - Nail Ø8mm | 210mm | Right
• B058AHN08210L1: Atlas Humeral Nail System - Nail Ø8mm | 210mm | Left
• B058AHN08180R1: Atlas Humeral Nail System - Nail Ø8mm | 180mm | Right
• B058AHN08180L1: Atlas Humeral Nail System - Nail Ø8mm | 180mm | Left
• B058AHN11C10L1: Atlas Humeral Nail System - End Cap - Locking - Ø11mm x 10mm
• B058AHN11C05L1: Atlas Humeral Nail System - End Cap - Locking - Ø11mm x 5mm
• B058AHN11C00L1: Atlas Humeral Nail System - End Cap - Locking - Ø11mm x Flush