Nano FortiFix® System

Thoracolumbosacral Pedicle Screw System

Nanovis LLC

The following data is part of a premarket notification filed by Nanovis Llc with the FDA for Nano Fortifix® System.

Pre-market Notification Details

• Device ID: K203452
• 510k Number: K203452
• Device Name: Nano FortiFix® System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Nanovis 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
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-11-23
• Decision Date: 2020-12-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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