Zavation Solid Standard Modular Screw

GUDID 00842166130081

Solid Standard Modular Screw 10.5x110

Zavation LLC

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00842166130081
• NIH Device Record Key: eddf5b41-2e80-4a03-815a-3ee306d11298
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zavation Solid Standard Modular Screw
• Version Model Number: 383-105110-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842166130081 [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

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

Moist Heat or Steam Sterilization

[00842166130081]

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

Devices Manufactured by Zavation LLC

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• 00197157016807 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 10° offset,5.5/6.0mm X 5.5/6.0mm
• 00197157016814 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 20°offset,5.5/6.0mm X 5.5/6.0mm
• 00197157016821 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, PARALLEL TOP LOADING 30°offset,5.5/6.0mm X 5.5/6.0mm
• 00197157016838 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,3.5/4.0mm X 4.75/5.5mm
• 00197157016845 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,3.5/4.0mm X 5.5/6.0mm
• 00197157016852 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,4.75/5.5mm X 4.75/5.5mm
• 00197157016869 - ZAVATION ROD CONNECTOR: 2025-06-13 ROD CONNECTOR, AXIAL CLOSED mm offset,4.75/5.5mm X 5.5/6.0mm