FDA 510(k)

Threshold V2 Pedicular Fixation System

K-Number: K170255 · 2017-04-14

Decision Date2017-04-14

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Threshold V2 Pedicular Fixation System is a medical device manufactured by Spineology, Inc.. It received FDA 510(k) clearance on 2017-04-14 under approval number K170255. 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 V2 Pedicular Fixation System?

Threshold V2 Pedicular Fixation System is a medical device that received FDA 510(k) clearance on 2017-04-14. It is manufactured by Spineology, Inc.. The 510(k) number is K170255.

When was Threshold V2 Pedicular Fixation System approved by the FDA?

Threshold V2 Pedicular Fixation System received FDA 510(k) clearance on 2017-04-14, under approval number K170255.

What company makes Threshold V2 Pedicular Fixation System?

Threshold V2 Pedicular Fixation System is manufactured by Spineology, Inc..

What is the FDA product code for Threshold V2 Pedicular Fixation System?

The FDA product code for Threshold V2 Pedicular Fixation System is NKB.

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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 K153323Palisade Pedicular Fixation System K153082Rampart A Lumbar Interbody Fusion Device

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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.