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FDA 510(k)

Certex Spinal Fixation System

K-Number: K160428 · 2016-05-05

ApplicantX-Spine Systems, Inc.
Decision Date2016-05-05
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Certex Spinal Fixation System is a medical device manufactured by X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2016-05-05 under approval number K160428. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Certex Spinal Fixation System?

Certex Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2016-05-05. It is manufactured by X-Spine Systems, Inc.. The 510(k) number is K160428.

When was Certex Spinal Fixation System approved by the FDA?

Certex Spinal Fixation System received FDA 510(k) clearance on 2016-05-05, under approval number K160428.

What company makes Certex Spinal Fixation System?

Certex Spinal Fixation System is manufactured by X-Spine Systems, Inc..

What is the FDA product code for Certex Spinal Fixation System?

The FDA product code for Certex Spinal Fixation System is NKG.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by X-Spine Systems, Inc.

K160959Xsert Lumbar Expandable Interbody System K162944Irix-C Cervical Integrated Fusion System K160114Xspan Laminoplasty Fixation System K170119Calix Lumbar Spinal Implant System K171567IRIX-A Lumbar Integrated Fusion System K171075Calix-C Cervical Interbody Spacer

View all 11 devices →

Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, 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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