Nano FortiFix® System
K-Number: K203452 · 2020-12-22
ApplicantNanovis, LLC
Decision Date2020-12-22
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Nano FortiFix® System is a medical device manufactured by Nanovis, LLC. It received FDA 510(k) clearance on 2020-12-22 under approval number K203452. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Nano FortiFix® System?
Nano FortiFix® System is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Nanovis, LLC. The 510(k) number is K203452.
When was Nano FortiFix® System approved by the FDA?
Nano FortiFix® System received FDA 510(k) clearance on 2020-12-22, under approval number K203452.
What company makes Nano FortiFix® System?
Nano FortiFix® System is manufactured by Nanovis, LLC.
What is the FDA product code for Nano FortiFix® System?
The FDA product code for Nano FortiFix® System is NKB.
Other Devices by Nanovis, LLC
K161485Nanovis Intervertebral Body Fusion System and Forticore(R)
K160874Nanovis Intervertebral Body Fusion System and FortiCore®
K171312FortiCore®
K191822Nano FortiCore, FortiCore
K230936Anatomic PEEK Cervical Fusion System with Nanotechnology
K241605Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology
Related Devices (Code: NKB)
K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.
K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC
K162912VIPER PRIME additions to the VIPER® SystemMedos International SARL
K162160Preference Elite Pedicle Screw SystemAmedica Corporation
K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG
K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.