Nano FortiFix System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K203452 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Anatomic PEEK™ Cervical Fusion System with Nanotechnology

  Class II

  FDA 510(k) K230936 Active Cleared 2 Jun 2023

• Nanovis Intervertebral Body Fusion System and FortiCore

  Class II

  FDA 510(k) K160874 Active Cleared 28 Jun 2016

• Nanovis Intervertebral Body Fusion System

  Class II

  FDA 510(k) K110442 Active Cleared 9 Nov 2011

• Nanovis Intervertebral Body Fusion System and Forticore(R)

  Class II

  FDA 510(k) K161485 Active Cleared 6 Sep 2016

• Nano FortiCore, FortiCore

  Class II

  FDA 510(k) K191822 Active Cleared 11 Oct 2019

• FortiCore®

  Class II

  FDA 510(k) K171312 Active Cleared 22 Jan 2018

See all devices from Nanovis, LLC →

• What is the Nano FortiFix System used for?

  The Nano FortiFix System is designed for use in spinal surgery as a pedicle screw system with nanotechnology designation. It includes an integrated extended tab system and dual lead cannulated screws to support orthopedic applications.

• How is the Nano FortiFix System supplied?

  The Nano FortiFix System is supplied as a complete product offering. It is manufactured by Nanovis, LLC and includes all components necessary for spinal surgical procedures.

• What regulatory status does the Nano FortiFix System have?

  The Nano FortiFix System is FDA cleared under 510(k) number K203452 with a decision code of SESE, indicating it is substantially equivalent to predicate devices. It is covered by U.S. patents 8399008, 8906402, and 10596001.

• What are the key features of the Nano FortiFix System?

  The Nano FortiFix System features an integrated extended tab system and dual lead cannulated screws. It is specifically designed for spinal surgery applications and incorporates nanotechnology designation to enhance its performance characteristics.