FortiBridge® 10701-1016

GUDID 00814216021557

FortiBridge Anterior Cervical Plate 1 Level x 16mm

NANOVIS SPINE, LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00814216021557
• NIH Device Record Key: dcd9de74-3447-4c49-9189-ba8f30952210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FortiBridge®
• Version Model Number: 10701-1016
• Catalog Number: 10701-1016
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814216021557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162250

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

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: 2019-05-24
• Device Publish Date: 2016-12-02

On-Brand Devices [FortiBridge®]

• 00814216022134: FortiBridgel Anterior Cervical Plate 4 Level x 81mm
• 00814216022127: FortiBridge Anterior Cervical Plate 4 Level x 77mm
• 00814216022110: FortiBridge Anterior Cervical Plate 4 level x 73mm
• 00814216022103: FortiBridge Anterior Cervical Plate 4 Level 69mm
• 00814216021854: FortiBridge® Variable Screw 4.5x16mm
• 00814216021847: FortiBridge® Variable Screw 4.5x14mm
• 00814216021830: FortiBridge® Variable Screw 4.5x12mm
• 00814216021823: FortiBridge® Variable Screw 4.5x10mm
• 00814216021816: FortiBridge® Fixed Screw 4.5x16mm
• 00814216021809: FortiBridge® Fixed Screw 4.5x14mm
• 00814216021793: FortiBridge® Fixed Screw 4.5x12mm
• 00814216021786: FortiBridge® Fixed Screw 4.5x10mm
• 00814216021779: FortiBridge Anterior Cervical Plate 3 Level x 69mm
• 00814216021762: FortiBridge Anterior Cervical Plate 3 Level x 66mm
• 00814216021755: FortiBridge Anterior Cervical Plate 3 Level x 63mm
• 00814216021748: FortiBridge Anterior Cervical Plate 3 Level x 66mm
• 00814216021731: FortiBridge Anterior Cervical Plate 3 Level x 57mm
• 00814216021724: FortiBridge Anterior Cervical Plate 3 Level x 54mm
• 00814216021717: FortiBridge Anterior Cervical Plate 3 Level x 51mm
• 00814216021700: FortiBridge Anterior Cervical Plate 3 Level x 48mm
• 00814216021694: FortiBridge Anterior Cervical Plate 2 Level x 46mm
• 00814216021687: FortiBridge Anterior Cervical Plate 2 Level x 44mm
• 00814216021670: FortiBridge Anterior Cervical Plate 2 Level x 42mm
• 00814216021663: FortiBridge Anterior Cervical Plate 2 Level x 40mm
• 00814216021656: FortiBridge Anterior Cervical Plate 2 Level x 38mm
• 00814216021649: FortiBridge Anterior Cervical Plate 2 Level x 36mm
• 00814216021632: FortiBridge Anterior Cervical Plate 2 Level x 34mm
• 00814216021625: FortiBridge Anterior Cervical Plate 2 Level x 32mm
• 00814216021618: FortiBridge Anterior Cervical Plate 2 Level x 30mm
• 00814216021601: FortiBridge Anterior Cervical Plate 2 Level x 28mm
• 00814216021595: FortiBridge Anterior Cervical Plate 1 Level x 24mm
• 00814216021588: FortiBridge Anterior Cervical Plate 1 Level x 22mm
• 00814216021571: FortiBridge Anterior Cervical Plate 1 Level x 20mm
• 00814216021564: FortiBridge Anterior Cervical Plate 1 Level 18mm
• 00814216021557: FortiBridge Anterior Cervical Plate 1 Level x 16mm
• 00814216021540: FortiBridge Anterior Cervical Plate 1 Level x 14mm
• 00814216021533: FortiBridge Anterior Cervical Plate 1 Level x 13mm
• 00814216021526: FortiBridge Anterior Cervical Plate 1 Level x 12mm
• 00814216021519: FortiBridge® Self-drill Variable Screw 4mm x 12mm
• 00814216021427: FortiBridge® 4.0 x 16 Self-Drill Screw, Fix
• 00814216021410: FortiBridge® 4.0 x 18 Self-Drill Screw, Fix
• 00814216021403: FortiBridge® 4.0 x 016 Self-Drill Screw, Fix
• 00814216021397: FortiBridge 4.0 x 14 Self-Drill Screw, Fixed
• 00814216021380: FortiBridge® 4.0 x 12 Self-Drill Screw, Fix
• 00814216021373: FortiBridge® Self-drill Fixed Screw 4.0 x 10
• 00814216021366: FortiBridge® Self-Drill Variable Screw 4.0 x 20
• 00814216021359: FortiBridge Self-drill Variable Screw 4.0 x 18
• 00814216021342: FortiBridge® Self-drill Variable Screw 4.0 x 16
• 00814216021335: FortiBridge® Self-drill Variable Screw 4.0 x 14
• 00814216021328: FortiBridge® Self-drill Variable Screw 4.0 x 12