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FDA 510(k)

Palisade Pedicular Fixation System

K-Number: K153323 · 2016-02-23

ApplicantSpineology, Inc.
Decision Date2016-02-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Palisade Pedicular Fixation System is a medical device manufactured by Spineology, Inc.. It received FDA 510(k) clearance on 2016-02-23 under approval number K153323. 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 Palisade Pedicular Fixation System?

Palisade Pedicular Fixation System is a medical device that received FDA 510(k) clearance on 2016-02-23. It is manufactured by Spineology, Inc.. The 510(k) number is K153323.

When was Palisade Pedicular Fixation System approved by the FDA?

Palisade Pedicular Fixation System received FDA 510(k) clearance on 2016-02-23, under approval number K153323.

What company makes Palisade Pedicular Fixation System?

Palisade Pedicular Fixation System is manufactured by Spineology, Inc..

What is the FDA product code for Palisade Pedicular Fixation System?

The FDA product code for Palisade Pedicular Fixation System is NKB.

Related Clinical Trials

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Other Devices by Spineology, Inc.

K160074Rampart D Lumbar Interbody Fusion Device K161694Threshold™ Pedicular Fixation System K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation System K153082Rampart A Lumbar Interbody Fusion Device K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System

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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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