FDA 510(k)

Threshold Pedicular Fixation System

K-Number: K170251 · 2017-04-14

Decision Date2017-04-14

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 2017-04-14 under approval number K170251. 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 2017-04-14. It is manufactured by Spineology, Inc.. The 510(k) number is K170251.

When was Threshold Pedicular Fixation System approved by the FDA?

Threshold Pedicular Fixation System received FDA 510(k) clearance on 2017-04-14, under approval number K170251.

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.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07531901 Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid NOT_YET_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT07561372 Adaptive Recruitment Curve Analysis Using Bayesian Modeling NOT_YET_RECRUITING NCT07593807 TMS Combined With Virtual Reality and Multidisciplinary Rehabilitation in Multiple Sclerosis ACTIVE_NOT_RECRUITING

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

View all 33 devices →

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.