Zavation Modular Screw

GUDID 00842166194809

Modular Screw 8.5x110

Zavation LLC

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00842166194809
• NIH Device Record Key: d01bd286-d82f-4bda-86fb-d10ad73caaff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation Modular Screw
• Version Model Number: 383-85110-S
• Company DUNS: 069472800
• Company Name: Zavation LLC
• 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: false
• 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: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842166194809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222614

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-20
• Device Publish Date: 2024-11-12

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• 00842166130081 - Zavation Solid Standard Modular Screw: 2024-11-20 Solid Standard Modular Screw 10.5x110
• 00842166194809 - Zavation Modular Screw: 2024-11-20 Modular Screw 8.5x110
• 00842166194809 - Zavation Modular Screw: 2024-11-20 Modular Screw 8.5x110