FortiBridge 10703-4018

GUDID 00814216022677

FortiBridge Variable Screw 4mm x 18mm

NANOVIS SPINE, LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00814216022677
• NIH Device Record Key: 5df28244-6d07-4520-bcfe-7df06b8ab118
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FortiBridge
• Version Model Number: 10703-4018
• Catalog Number: 10703-4018
• 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: 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: 877-907-6266
• Email: nanovisquality@nanovistechnology.com

Device Dimensions

• Length: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814216022677 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143706

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: 3
• Public Version Date: 2019-05-27
• Device Publish Date: 2019-03-04

On-Brand Devices [FortiBridge]

• 00814216023544: 16mm single use drill
• 00814216022691: FortiBridge Self-tap Fixed Screw 4.0x18mm
• 00814216022646: FortiBridge Anterior Cervical Plate 1 level 12mm ACP
• 00814216023643: FortiBridge Beta 2 Instrument Case Assembly
• 00814216023636: FortiBridge Beta 2.0 Implant Case Assembly
• 00814216023582: Sgl Barrel Drill Guide - Fix custom
• 00814216023575: Sgl Barrel Drill Guide - Fix
• 00814216023551: Sgl Barrel Drill Guide - Var
• 00814216023537: 14mm single use drill
• 00814216023520: 12mm single use drill
• 00814216023513: 10mm single use drill
• 00814216023506: FortiBridge Anterior Cervical Plate 4 Level x 85mm
• 00814216023490: FortiBridge Anterior Cervical Plate 4 Level x 81mm
• 00814216023483: FortiBridge Anterior Cervical Plate 4 Level x 77mm
• 00814216023476: FortiBridge Anterior Cervical Plate 4 Level x 73mm
• 00814216023469: FortiBridge Anterior Cervical Plate 4 level x 69mm
• 00814216023452: FortiBridge Anterior Cervical Plate 4 level x 65mm
• 00814216023445: FortiBridge Anterior Cervical Plate 4 Level x 61mm
• 00814216023438: FortiBridge Anterior Cervical Plate 3 Level x 69mm
• 00814216023421: FortiBridge Anterior Cervical Plate 3 Level x 66mm
• 00814216023414: FortiBridge Anterior Cervical Plate 3 Level x 63mm
• 00814216023407: FortiBridge Anterior Cervical Plate 3 Level x 60mm
• 00814216023391: FortiBridge Anterior Cervical Plate 3 Level x 57mm
• 00814216023384: FortiBridge Anterior Cervical Plate 3 Level x 54mm
• 00814216023377: FortiBridge Anterior Cervical Plate 3 Level x 51mm
• 00814216023360: FortiBridge Anterior Cervical Plate 3 Level x 48mm
• 00814216023353: FortiBridge Anterior Cervical Plate 3 Level x 45mm
• 00814216023346: FortiBridge Anterior Cervical Plate 2 Level x 46mm
• 00814216023339: FortiBridge Anterior Cervical Plate 2 Level x 44mm
• 00814216023322: FortiBridge Anterior Cervical Plate 2 Level x 42mm
• 00814216023315: Fortibridge Anterior Cervial Plate 2 Level x 40mm
• 00814216023308: FortiBridge Anterior Cervical Plate 2 Level x 38mm
• 00814216023292: FortiBridge Anterior Cervical Plate 2 Level x 36mm
• 00814216023285: FortiBridge Anterior Cervical Plate 2 level x 34mm
• 00814216023278: FortiBridge Anterior Cervical Plate 2 Level x 32mm
• 00814216023261: FortiBridge Anterior Cervical Plate 2 Level 30mm
• 00814216023254: FortiBridge Anterior Cervical Plate 2 Level 28mm
• 00814216023247: FortiBridge Anterior Cervical Plate 1 level 24mm
• 00814216023230: FortiBridge Anterior Cervical Plate 1 Level x 22mm
• 00814216023223: FortiBridge Anterior Cervical Plate 1 Level x 20mm
• 00814216023216: FortiBridge Anterior Cervical Plate 1 Level x 18mm.
• 00814216023209: FortiBridge Anterior Cervical Plate 1 Level x 16mm
• 00814216022677: FortiBridge Variable Screw 4mm x 18mm
• 00814216022660: FortiBridge Anterior Cervical Plate 1 Level x 14mm
• 00814216022653: FortiBridge Anterior Cervical Plate 1 Level by 13mm
• 00814216022387: FortiBridge Self Tapping Fixed Screw 4.0 x 16mm
• 00814216023568: Sgl Barrel Drill Guide - Var custom
• 00814216023629: ACP Distraction Adapter
• 00814216023612: ACP Cam Driver
• 00814216023605: ACP DBL Barrel Drill Guide - Fix