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FDA 510(k)

MEGAFIX® Pedicle Screw Spinal System

K-Number: K191655 · 2020-03-06

ApplicantSeohancare Co., Ltd.
Decision Date2020-03-06
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEGAFIX® Pedicle Screw Spinal System is a medical device manufactured by Seohancare Co., Ltd.. It received FDA 510(k) clearance on 2020-03-06 under approval number K191655. 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 MEGAFIX® Pedicle Screw Spinal System?

MEGAFIX® Pedicle Screw Spinal System is a medical device that received FDA 510(k) clearance on 2020-03-06. It is manufactured by Seohancare Co., Ltd.. The 510(k) number is K191655.

When was MEGAFIX® Pedicle Screw Spinal System approved by the FDA?

MEGAFIX® Pedicle Screw Spinal System received FDA 510(k) clearance on 2020-03-06, under approval number K191655.

What company makes MEGAFIX® Pedicle Screw Spinal System?

MEGAFIX® Pedicle Screw Spinal System is manufactured by Seohancare Co., Ltd..

What is the FDA product code for MEGAFIX® Pedicle Screw Spinal System?

The FDA product code for MEGAFIX® Pedicle Screw Spinal 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: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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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