FortiCore PLIF 104099-0005

GUDID 00814216023674

PLIF FortiCore Inserter2 - 90 degree handle

NANOVIS SPINE, LLC

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00814216023674
• NIH Device Record Key: 79e5b51d-d1d9-4c0f-a80f-34018abeb048
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FortiCore PLIF
• Version Model Number: 10499-0005
• Catalog Number: 104099-0005
• 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: false
• 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

Customer Support Contacts

• Phone: 8779076266
• Email: nanovisquality@nanovistechnology.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814216023674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110442

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00814216023674]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-04-22

On-Brand Devices [FortiCore PLIF]

• 00814216023681: FortiCore® PLIF Trial (7x9.5x22,6°)
• 00814216023674: PLIF FortiCore Inserter2 - 90 degree handle
• 00814216023650: PLIF Inserter - 90 degree handle