FDA 510(k)

Threshold Pedicular Fixation System

K-Number: K161694 · 2016-07-15

Decision Date2016-07-15

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Threshold Pedicular Fixation System is a medical device manufactured by Spineology, Inc.. It received FDA 510(k) clearance on 2016-07-15 under approval number K161694. 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 Threshold Pedicular Fixation System?

Threshold Pedicular Fixation System is a medical device that received FDA 510(k) clearance on 2016-07-15. It is manufactured by Spineology, Inc.. The 510(k) number is K161694.

When was Threshold Pedicular Fixation System approved by the FDA?

Threshold Pedicular Fixation System received FDA 510(k) clearance on 2016-07-15, under approval number K161694.

What company makes Threshold Pedicular Fixation System?

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

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

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

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Other Devices by Spineology, Inc.

K160074Rampart D Lumbar Interbody Fusion Device 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 K153323Palisade 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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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.