FDA 510(k)

Zenius Spinal System

K-Number: K232218 · 2023-08-24

Decision Date2023-08-24

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Zenius Spinal System is a medical device manufactured by Medyssey USA, Inc.. It received FDA 510(k) clearance on 2023-08-24 under approval number K232218. 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 Zenius Spinal System?

Zenius Spinal System is a medical device that received FDA 510(k) clearance on 2023-08-24. It is manufactured by Medyssey USA, Inc.. The 510(k) number is K232218.

When was Zenius Spinal System approved by the FDA?

Zenius Spinal System received FDA 510(k) clearance on 2023-08-24, under approval number K232218.

What company makes Zenius Spinal System?

Zenius Spinal System is manufactured by Medyssey USA, Inc..

What is the FDA product code for Zenius Spinal System?

The FDA product code for Zenius Spinal System is NKB.

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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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.