FortiBridge Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Nanovis Spine LLC

The following data is part of a premarket notification filed by Nanovis Spine Llc with the FDA for Fortibridge Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K143706
• 510k Number: K143706
• Device Name: FortiBridge Anterior Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Nanovis Spine LLC 5865 East State Rd. 14 Columbia City, IN 46725
• Contact: Matthew Hedrick
• Correspondent: Karen E Warden; BackRoads Consulting Inc. PO Box 566 Chesterland, OH 44026 -2141
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-29
• Decision Date: 2015-04-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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