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: K162250
• 510k Number: K162250
• 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-10
• Decision Date: 2016-10-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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