Dual Core Cortical Locking Screw HTN-U-4-36

GUDID B058HTNU4361

Dual Core Cortical Locking Screw - Ø4mm x 36mm

Orthopedic Designs North America, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: B058HTNU4361
• NIH Device Record Key: 316b0c31-7aa1-4dff-8f52-3bb8ca2ac5f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Core Cortical Locking Screw
• Version Model Number: HTNU436
• Catalog Number: HTN-U-4-36
• 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

Device Dimensions

• Outer Diameter: 4 Millimeter
• Length: 36 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058HTNU4361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173255

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[B058HTNU4361]

Moist Heat or Steam Sterilization

[B058HTNU4361]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-21

On-Brand Devices [Dual Core Cortical Locking Screw]

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• B058HTNU4581: Dual Core Cortical Locking Screw - Ø4mm x 58mm
• B058HTNU4561: Dual Core Cortical Locking Screw - Ø4mm x 56mm
• B058HTNU4541: Dual Core Cortical Locking Screw - Ø4mm x 54mm
• B058HTNU4521: Dual Core Cortical Locking Screw - Ø4mm x 52mm
• B058HTNU4501: Dual Core Cortical Locking Screw - Ø4mm x 50mm
• B058HTNU4481: Dual Core Cortical Locking Screw - Ø4mm x 48mm
• B058HTNU4461: Dual Core Cortical Locking Screw - Ø4mm x 46mm
• B058HTNU4441: Dual Core Cortical Locking Screw - Ø4mm x 44mm
• B058HTNU4421: Dual Core Cortical Locking Screw - Ø4mm x 42mm
• B058HTNU4401: Dual Core Cortical Locking Screw - Ø4mm x 40mm
• B058HTNU4381: Dual Core Cortical Locking Screw - Ø4mm x 38mm
• B058HTNU4361: Dual Core Cortical Locking Screw - Ø4mm x 36mm
• B058HTNU4341: Dual Core Cortical Locking Screw - Ø4mm x 34mm
• B058HTNU4321: Dual Core Cortical Locking Screw - Ø4mm x 32mm
• B058HTNU4301: Dual Core Cortical Locking Screw - Ø4mm x 30mm
• B058HTNU4281: Dual Core Cortical Locking Screw - Ø4mm x 28mm
• B058HTNU4261: Dual Core Cortical Locking Screw - Ø4mm x 26mm
• B058HTNU4241: Dual Core Cortical Locking Screw - Ø4mm x 24mm
• B058HTNU4221: Dual Core Cortical Locking Screw - Ø4mm x 22mm
• B058HTNU4201: Dual Core Cortical Locking Screw - Ø4mm x 20mm
• B058HTNU4181: Dual Core Cortical Locking Screw - Ø4mm x 18mm