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FDA 510(k)

KHEIRON Spinal Fixation System

K-Number: K211414 · 2021-08-10

ApplicantS.M.A.I.O
Decision Date2021-08-10
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 2021-08-10 under approval number K211414. 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 2021-08-10. It is manufactured by S.M.A.I.O. The 510(k) number is K211414.

When was KHEIRON Spinal Fixation System approved by the FDA?

KHEIRON Spinal Fixation System received FDA 510(k) clearance on 2021-08-10, under approval number K211414.

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: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Other Devices by S.M.A.I.O

K201659KHEIRON® 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

View all 10 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.

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