FDA 510(k)

Revolution Spinal Fixation System

K-Number: K163056 · 2017-02-24

ApplicantIntelligent Implant Systems, LLC

Decision Date2017-02-24

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Revolution Spinal Fixation System is a medical device manufactured by Intelligent Implant Systems, LLC. It received FDA 510(k) clearance on 2017-02-24 under approval number K163056. 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 Revolution Spinal Fixation System?

Revolution Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-02-24. It is manufactured by Intelligent Implant Systems, LLC. The 510(k) number is K163056.

When was Revolution Spinal Fixation System approved by the FDA?

Revolution Spinal Fixation System received FDA 510(k) clearance on 2017-02-24, under approval number K163056.

What company makes Revolution Spinal Fixation System?

Revolution Spinal Fixation System is manufactured by Intelligent Implant Systems, LLC.

What is the FDA product code for Revolution Spinal Fixation System?

The FDA product code for Revolution Spinal Fixation 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 Intelligent Implant Systems, LLC

K160216Revolution Spinal Fixation System K173935Mediant Anterior Cervical Plating System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.