FortiCore Cervical Trial 11893-1608

GUDID 00814216024176

FortiCore Cervical Trial 14x16x8, 6° with a stop

NANOVIS SPINE, LLC

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00814216024176
• NIH Device Record Key: 3986d9f6-07f0-42d9-af33-10cad52e2e21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FortiCore Cervical Trial
• Version Model Number: 11893-1608
• Catalog Number: 11893-1608
• 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 Dimensions

• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814216024176 [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

[00814216024176]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-10-17

On-Brand Devices [FortiCore Cervical Trial]

• 00814216024169: FortiCore Cervical Trial 14x16x7, 6° with a stop
• 00814216024152: FortiCore Cervical Trial 14x16x6, 6° with a stop
• 00814216024589: FortiCore Cervical Trial 14x12 5mm
• 00814216024572: FortiCore Cervical Trial 14x12 6mm
• 00814216024565: FortiCore Cervical Trial 14x12 7mm
• 00814216024558: FortiCore Cervical Trial 14x12 8mm
• 00814216024541: FortiCore Cervical Trial 14x12 9mm
• 00814216024534: FortiCore Cervical Trial 14x12 10mm
• 00814216024527: FortiCore Cervical Trial 14x12 11mm
• 00814216024510: FortiCore Cervical Trial 14x12 12mm
• 00814216024503: FortiCore Cervical Trial 16x14 12mm
• 00814216024497: FortiCore Cervical Trial 16x14 11mm
• 00814216024480: FortiCore Cervical Trial 16x14 10mm
• 00814216024473: FortiCore Cervical Trial 16x14 9mm
• 00814216024466: FortiCore Cervical Trial 16x14 8mm
• 00814216024459: FortiCore Cervical Trial 16x14 7mm
• 00814216024435: FortiCore Cervical Trial 16x14 6mm
• 00814216024428: FortiCore Cervical Trial 16x14 5mm
• 00814216024176: FortiCore Cervical Trial 14x16x8, 6° with a stop
• 00814216024220: FortiCore Cervical Trial 12x14x9, 6° with a stop
• 00814216024213: FortiCore Cervical Trial 12x14x8, 6° with a stop
• 00814216024206: FortiCore Cervical Trial 12x14x7, 6° with a stop
• 00814216024190: FortiCore Cervical Trial 12x14x6, 6° with a stop
• 00814216024183: FortiCore Cervical Trial 14x16x9, 6° with a stop