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FDA 510(k)

Invictus® Spinal Fixation System

K-Number: K214006 · 2022-04-04

ApplicantAlphatec Spine, Inc.
Decision Date2022-04-04
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Invictus® Spinal Fixation System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2022-04-04 under approval number K214006. 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 Invictus® Spinal Fixation System?

Invictus® Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-04-04. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K214006.

When was Invictus® Spinal Fixation System approved by the FDA?

Invictus® Spinal Fixation System received FDA 510(k) clearance on 2022-04-04, under approval number K214006.

What company makes Invictus® Spinal Fixation System?

Invictus® Spinal Fixation System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for Invictus® Spinal Fixation System?

The FDA product code for Invictus® Spinal Fixation System is NKB.

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 Alphatec Spine, Inc.

K160646XYcor® Expandable Spinal Spacer System K161363Arsenal Spinal Fixation System K153603Alphatec Navigation Instruments K173522Solanas® Posterior Stabilization System K182746ATEC ALIF and LLIF Spacer System K182808Aspida® Anterior Lumbar Plating 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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