InterFuse S 9076-11-20-5-B

GUDID 00819475010441

Intervertebral Body Fusion Device

VERTEBRAL TECHNOLOGIES, INC.

Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: 00819475010441
• NIH Device Record Key: 98ec9685-4cc0-424a-8119-08ed4ae7128f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterFuse S
• Version Model Number: 9076-11-20-5-B
• Catalog Number: 9076-11-20-5-B
• Company DUNS: 362264421
• Company Name: VERTEBRAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• 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: 952-912-5400
• Email: CustomerService@vti-spine.com
• Phone: 952-912-5400
• Email: CustomerService@vti-spine.com

Device Dimensions

• Angle: 5 degree
• Angle: 5 degree
• Angle: 5 degree
• Angle: 5 degree
• Angle: 5 degree
• Angle: 5 degree

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Ambient temperatures in a clean dry area
• Special Storage Condition, Specify: Between 0 and 0 *Ambient temperatures in a clean dry area

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819475010441 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-15

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