Nanovis Intervertebral Body Fusion System and FortiCore

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

510(k) Number

K160874 ↗

FDA Product Code

MAX

Device Class

Class II

Regulation

21 CFR Part 888.3080

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

  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

• Nano FortiFix System

  Class II

  FDA 510(k) K203452 Active Cleared 22 Dec 2020

• FortiCore®

  Class II

  FDA 510(k) K171312 Active Cleared 22 Jan 2018

See all devices from Nanovis, LLC →

• What is the Nanovis Intervertebral Body Fusion System and FortiCore used for?

  The Nanovis Intervertebral Body Fusion System and FortiCore is an orthopedic device designed for intervertebral body fusion procedures. It provides structural support and promotes bone growth between vertebrae to facilitate spinal fusion.

• Is the Nanovis Intervertebral Body Fusion System single-use or reusable?

  The device is supplied as a single-use system, meaning it should be used for one patient only and then discarded according to medical waste disposal protocols.

• What sizes and models are available for the Nanovis Intervertebral Body Fusion System?

  The device is available in various sizes and models as specified by the manufacturer, Nanovis, LLC. The specific sizes and models should be selected based on the patient's anatomy and the surgical requirements.

• How should the Nanovis Intervertebral Body Fusion System be stored?

  The device should be stored according to the manufacturer's instructions. Proper storage conditions are essential to maintain the integrity and functionality of the device until it is ready for use in a surgical procedure.

• What is the regulatory status of the Nanovis Intervertebral Body Fusion System?

  The device is regulated under FDA 510K clearance with product code MAX. This means it has been determined to be substantially equivalent to other legally marketed devices of the same type.