FortiBridgeTM

GUDID 00814216020291

FortiBridgeTM Anterior Cervical Plate 3 Level 51mm

NANOVIS SPINE, LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00814216020291
• NIH Device Record Key: f1e4b181-3985-4168-a88d-195971934b1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FortiBridgeTM
• Version Model Number: 10701-3051
• 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: 51 Millimeter
• Device Size Text, specify: 0
• Length: 51 Millimeter
• Device Size Text, specify: 0
• Length: 51 Millimeter
• Device Size Text, specify: 0
• Length: 51 Millimeter
• Device Size Text, specify: 0
• Length: 51 Millimeter
• Device Size Text, specify: 0
• Length: 51 Millimeter
• Device Size Text, specify: 0
• Length: 51 Millimeter
• Device Size Text, specify: 0
• Length: 51 Millimeter
• Device Size Text, specify: 0
• Length: 51 Millimeter
• Device Size Text, specify: 0
• Length: 51 Millimeter
• Device Size Text, specify: 0
• Length: 51 Millimeter
• Device Size Text, specify: 0
• Length: 51 Millimeter
• Device Size Text, specify: 0
• Length: 51 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814216020291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143706

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

[00814216020291]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-10
• Device Publish Date: 2015-09-15

On-Brand Devices [FortiBridgeTM]

• 00814216024725: FortiBridge Anterior Cervical Plate 3 Level x 45mm
• 00814216024718: FortiBridge Anterior Cervical Plate 4 Level x 65mm
• 00814216024701: FortiBridge Anterior Cervical Plate 4 Level x 65mm
• 00814216024695: FortiBridge Anterior Cervical Plate 3 Level x 45mm
• 00814216020635: FortiBridge Fixed Screw 4.5mm x 16mm
• 00814216020628: FortiBridge Fixed Screw 4.5mm x 14mm
• 00814216020611: FortiBridge Fixed Screw 4.5mm x 12mm
• 00814216020604: FortiBridge Fixed Screw 4.5mm x 10mm
• 00814216020598: FortiBridge Self-Tap Fixed Screw 4.0mm x 16mm
• 00814216020581: FortiBridge Self-Tap Fixed Screw 4.0mm x 14mm
• 00814216020574: FortiBridge Self-Tap Fixed Screw 4.0mm x 12mm
• 00814216020567: FortiBridge Self-Tap Fixed Screw 4.0mm x 10mm
• 00814216020550: FortiBridge Variable Screw 4.5mm x 16mm
• 00814216020543: FortiBridge Variable Screw 4.5mm x 14mm
• 00814216020536: FortiBridge Variable Screw 4.5mm x 12mm
• 00814216020529: FortiBridge Variable Screw 4.5mm x 10mm
• 00814216020512: FortiBridge Self-Tap Variable Screw 4mm x 16mm
• 00814216020505: FortiBridge Self-tap Variable Screw 4mm x 14mm
• 00814216020499: FortiBridge Self-tap Variable Screw 4mm x 12mm
• 00814216020482: FortiBridge ® Self-tap Variable Screw 4mm x 10mm
• 00814216020475: FortiBridge Anterior Cervical Plate 4 Level 101mm
• 00814216020468: FortiBridge Anterior Cervical Plate 4 Level 97mm
• 00814216020451: FortiBridge Anterior Cervical Plate 4 Level 93mm
• 00814216020444: FortiBridgeTM Anterior Cervical Plate 4 Level 89mm
• 00814216020437: FortiBridgeTM Anterior Cervical Plate 4 Level 85mm
• 00814216020420: FortiBridgeTM Anterior Cervical Plate 4 Level 81mm
• 00814216020413: FortiBridgeTM Anterior Cervical Plate 4 Level 77mm
• 00814216020406: FortiBridgeTM Anterior Cervical Plate 4 Level 73mm
• 00814216020390: FortiBridgeTM Anterior Cervical Plate 4 Level 69mm
• 00814216020383: FortiBridgeTM Anterior Cervical Plate 3 Level 78mm
• 00814216020376: FortiBridgeTM Anterior Cervical Plate 3 Level 75mm
• 00814216020369: FortiBridgeTM Anterior Cervical Plate 3 Level 72mm
• 00814216020352: FortiBridge Anterior Cervical Plate 3 Level 69mm
• 00814216020345: FortiBridgeTM Anterior Cervical Plate 3 Level 66mm
• 00814216020338: FortiBridge Anterior Cervical Plate 3 Level 63mm
• 00814216020321: FortiBridgeTM Anterior Cervical Plate 3 Level 60mm
• 00814216020314: FortiBridgeTM Anterior Cervical Plate 3 Level 57mm
• 00814216020307: FortiBridgeTM Anterior Cervical Plate 3 Level 54mm
• 00814216020291: FortiBridgeTM Anterior Cervical Plate 3 Level 51mm
• 00814216020284: FortiBridgeTM Anterior Cervical Plate 3 Level 48mm
• 00814216020277: FortiBridgeTM Anterior Cervical Plate 2 Level 54mm
• 00814216020260: FortiBridgeTM Anterior Cervical Plate 2 Level 52mm
• 00814216020253: FortiBridgeTM Anterior Cervical Plate 2 Level 50mm
• 00814216020246: FortiBridgeTM Anterior Cervical Plate 2 Level 48mm
• 00814216020239: FortiBridgeTM Anterior Cervical Plate 2 Level 46mm
• 00814216020222: FortiBridgeTM Anterior Cervical Plate 2 Level 44mm
• 00814216020215: FortiBridgeTM Anterior Cervical Plate 2 Level 42mm
• 00814216020208: FortiBridgeTM Anterior Cervical Plate 2 Level 40mm
• 00814216020192: FortiBridgeTM Anterior Cervical Plate 2 Level 38mm
• 00814216020185: FortiBridgeTM Anterior Cervical Plate 2 Level 36mm