InterFuse L 9119-08-21-55-0

GUDID 00819475010649

Intervertebral Body Fusion Device

VERTEBRAL TECHNOLOGIES, INC.

Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: 00819475010649
• NIH Device Record Key: f50d1a5f-437e-4856-8ef6-6598012ce1ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterFuse L
• Version Model Number: 9119-08-21-55-0
• Catalog Number: 9119-08-21-55-0
• 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: 0 degree
• Angle: 0 degree
• Angle: 0 degree
• Angle: 0 degree
• Angle: 0 degree
• Angle: 0 degree
• Angle: 0 degree
• Angle: 0 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	00819475010649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131540

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: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-15

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