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FDA 510(k)

Zenius Spinal System

K-Number: K170964 · 2017-04-26

ApplicantMedyssey USA, Inc.
Decision Date2017-04-26
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 2017-04-26 under approval number K170964. 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 2017-04-26. It is manufactured by Medyssey USA, Inc.. The 510(k) number is K170964.

When was Zenius Spinal System approved by the FDA?

Zenius Spinal System received FDA 510(k) clearance on 2017-04-26, under approval number K170964.

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.

Related Clinical Trials

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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)

Other Devices by Medyssey USA, Inc.

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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.

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