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FDA 510(k)

Patriot Spinal Fixation System

K-Number: K180324 · 2018-04-06

ApplicantValorus Spine
Decision Date2018-04-06
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Patriot Spinal Fixation System is a medical device manufactured by Valorus Spine. It received FDA 510(k) clearance on 2018-04-06 under approval number K180324. 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 Patriot Spinal Fixation System?

Patriot Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2018-04-06. It is manufactured by Valorus Spine. The 510(k) number is K180324.

When was Patriot Spinal Fixation System approved by the FDA?

Patriot Spinal Fixation System received FDA 510(k) clearance on 2018-04-06, under approval number K180324.

What company makes Patriot Spinal Fixation System?

Patriot Spinal Fixation System is manufactured by Valorus Spine.

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

The FDA product code for Patriot Spinal Fixation System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Other Devices by Valorus Spine

K172585Liberty Anterior Cervical Plate

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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