SCARLET® AC-T Secured Anterior Cervical Cage SCA-AC TL 07-S

GUDID 07640151085087

Secured Anterior Cervical Cage / Large

SpineArt SA

Metallic spinal interbody fusion cage

• Primary Device ID: 07640151085087
• NIH Device Record Key: cc34f10f-ed59-4f4b-8321-83a04d651328
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCARLET® AC-T Secured Anterior Cervical Cage
• Version Model Number: SCA-AC TL 07-S
• Catalog Number: SCA-AC TL 07-S
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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

Device Dimensions

• Depth: 14 Millimeter
• Depth: 14 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter
• Width: 17 Millimeter
• Height: 7 Millimeter
• Depth: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640151085087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143214

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-10-01

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• 07640151088569: Secured Lordotic Anterior Cervical Cage / Small
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• 07640151085186: Cervical Revision Screw
• 07640151085179: Cervical Revision Screw
• 07640151085162: Cervical Revision Screw
• 07640151085155: Cervical Screw
• 07640151085148: Cervical Screw
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• 07640185341791: Self-drilling cervical screw
• 07640185341784: Self-drilling cervical screw
• 07640185341777: Self-drilling cervical screw
• 07640185341760: Self-drilling cervical screw
• 07640185341753: Self-drilling cervical screw
• 07640185341746: Self-drilling cervical screw
• 07640185341739: Self-drilling cervical screw
• 07640185340893: UNIVERSAL JOINT DRIVER