FortiBridgeTM

GUDID 00814216020307

FortiBridgeTM Anterior Cervical Plate 3 Level 54mm

NANOVIS SPINE, LLC

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

Primary Device ID	00814216020307
NIH Device Record Key	2ab04e26-5187-4d07-8d0d-f198e476be27
Commercial Distribution Status	In Commercial Distribution
Brand Name	FortiBridgeTM
Version Model Number	10701-3054
Company DUNS	079898044
Company Name	NANOVIS SPINE, LLC
Device Count	1
DM Exempt	true
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	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	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
Email	nanovisquality@nanovistechnology.com
Phone	877-907-6266
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	54 Millimeter
Device Size Text, specify	0
Length	54 Millimeter
Device Size Text, specify	0
Length	54 Millimeter
Device Size Text, specify	0
Length	54 Millimeter
Device Size Text, specify	0
Length	54 Millimeter
Device Size Text, specify	0
Length	54 Millimeter
Device Size Text, specify	0
Length	54 Millimeter
Device Size Text, specify	0
Length	54 Millimeter
Device Size Text, specify	0
Length	54 Millimeter
Device Size Text, specify	0
Length	54 Millimeter
Device Size Text, specify	0
Length	54 Millimeter
Device Size Text, specify	0
Length	54 Millimeter
Device Size Text, specify	0
Length	54 Millimeter
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814216020307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K143706

FDA Product Code

KWQ	Appliance, Fixation, Spinal Intervertebral Body