FortiCore® 11407-3217N

GUDID 00814216023162

FortiCore® PLIF Spacer 12x17x32, (6°)

NANOVIS SPINE, LLC

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00814216023162
• NIH Device Record Key: 10413f04-d071-42a6-a434-39a6cd5ea0de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FortiCore®
• Version Model Number: 11407-3217N
• Catalog Number: 11407-3217N
• Company DUNS: 079898044
• Company Name: NANOVIS SPINE, 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: 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: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com
• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com

Device Dimensions

• Height: 17 Millimeter
• Width: 12 Millimeter
• Length: 32 Millimeter
• Height: 17 Millimeter
• Width: 12 Millimeter
• Length: 32 Millimeter
• Height: 17 Millimeter
• Width: 12 Millimeter
• Length: 32 Millimeter
• Height: 17 Millimeter
• Width: 12 Millimeter
• Length: 32 Millimeter
• Height: 17 Millimeter
• Width: 12 Millimeter
• Length: 32 Millimeter
• Height: 17 Millimeter
• Width: 12 Millimeter
• Length: 32 Millimeter
• Height: 17 Millimeter
• Width: 12 Millimeter
• Length: 32 Millimeter
• Height: 17 Millimeter
• Width: 12 Millimeter
• Length: 32 Millimeter
• Height: 17 Millimeter
• Width: 12 Millimeter
• Length: 32 Millimeter
• Height: 17 Millimeter
• Width: 12 Millimeter
• Length: 32 Millimeter
• Height: 17 Millimeter
• Width: 12 Millimeter
• Length: 32 Millimeter
• Height: 17 Millimeter
• Width: 12 Millimeter
• Length: 32 Millimeter
• Height: 17 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814216023162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161485

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: 2019-04-23

On-Brand Devices [FortiCore®]

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• 00814216021052: FortiCore® Flat Cervical Spacer 8x16x14, (6°)
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• 00814216021038: FortiCore® Flat Cervical Spacer 6x16x14, (6°)
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• 00814216020857: FortiCore® TLIF Spacer 15x13x29, (6°)
• 00814216020840: FortiCore® TLIF Spacer 14x13x29, (6°)