Cannulated Compression Device (CCD) System CCD-75-16-085NS

GUDID B058CCD7516085NS1

Cannulated Compression Device - 085mm - 16mm (non-sterile)

Orthopedic Designs North America, Inc.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: B058CCD7516085NS1
• NIH Device Record Key: 5452e96e-7c73-423a-8f08-5ff6b1e48c9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannulated Compression Device (CCD) System
• Version Model Number: CCD7516085NS
• Catalog Number: CCD-75-16-085NS
• 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

Device Dimensions

• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B058CCD7516085NS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210146

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

[B058CCD7516085NS1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-29
• Device Publish Date: 2024-07-19

On-Brand Devices [Cannulated Compression Device (CCD) System]

• B058CCD7516095NS1: Cannulated Compression Device - 095mm - 16mm (non-sterile)
• B058CCD7516090NS1: Cannulated Compression Device - 090mm - 16mm (non-sterile)
• B058CCD7516085NS1: Cannulated Compression Device - 085mm - 16mm (non-sterile)
• B058CCD7516080NS1: Cannulated Compression Device - 080mm - 16mm (non-sterile)
• B058CCD7516075NS1: Cannulated Compression Device - 075mm - 16mm (non-sterile)
• B058CCD7516070NS1: Cannulated Compression Device - 070mm - 16mm (non-sterile)
• B058CCD7516065NS1: Cannulated Compression Device - 065mm - 16mm (non-sterile)
• B058CCD7516060NS1: Cannulated Compression Device - 060mm - 16mm (non-sterile)
• B058CCD7516055NS1: Cannulated Compression Device - 055mm - 16mm (non-sterile)
• B058CCD7516050NS1: Cannulated Compression Device - 050mm - 16mm (non-sterile)
• B058CCD7516045NS1: Cannulated Compression Device - 045mm - 16mm (non-sterile)
• B058CCD0915NS1: CCD Compression Nut - Neutral (non-sterile)
• B058CCD0912NS1: CCD Compression Nut - Compressive (non-sterile)