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FDA 510(k)

X-spine Cortical Bone Screw System

K-Number: K180153 · 2018-03-15

ApplicantX-Spine Systems, Inc.
Decision Date2018-03-15
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-spine Cortical Bone Screw System is a medical device manufactured by X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2018-03-15 under approval number K180153. 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 X-spine Cortical Bone Screw System?

X-spine Cortical Bone Screw System is a medical device that received FDA 510(k) clearance on 2018-03-15. It is manufactured by X-Spine Systems, Inc.. The 510(k) number is K180153.

When was X-spine Cortical Bone Screw System approved by the FDA?

X-spine Cortical Bone Screw System received FDA 510(k) clearance on 2018-03-15, under approval number K180153.

What company makes X-spine Cortical Bone Screw System?

X-spine Cortical Bone Screw System is manufactured by X-Spine Systems, Inc..

What is the FDA product code for X-spine Cortical Bone Screw System?

The FDA product code for X-spine Cortical Bone Screw System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT07594483 Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium NOT_YET_RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING

Other Devices by X-Spine Systems, Inc.

K160959Xsert Lumbar Expandable Interbody System K162944Irix-C Cervical Integrated Fusion System K160428Certex Spinal Fixation System K160114Xspan Laminoplasty Fixation System K170119Calix Lumbar Spinal Implant System K171567IRIX-A Lumbar Integrated Fusion 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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