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FDA 510(k)

KHEIRON® Spinal Fixation System

K-Number: K201659 · 2020-10-05

ApplicantS.M.A.I.O
Decision Date2020-10-05
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KHEIRON® Spinal Fixation System is a medical device manufactured by S.M.A.I.O. It received FDA 510(k) clearance on 2020-10-05 under approval number K201659. 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 KHEIRON® Spinal Fixation System?

KHEIRON® Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2020-10-05. It is manufactured by S.M.A.I.O. The 510(k) number is K201659.

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

KHEIRON® Spinal Fixation System received FDA 510(k) clearance on 2020-10-05, under approval number K201659.

What company makes KHEIRON® Spinal Fixation System?

KHEIRON® Spinal Fixation System is manufactured by S.M.A.I.O.

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

The FDA product code for KHEIRON® 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 S.M.A.I.O

K211414KHEIRON Spinal Fixation System K211981KHEIRON® Spinal Fixation System K213975KEOPS Balance Analyzer 3D K232650KHEIRON® Spinal Fixation System, including patient specific K-ROD K223841KBA3D K253721KHEIRON® Spinal Fixation System, including patient specific K-ROD

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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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