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FDA 510(k)

Mikron Spinal Fixation System

K-Number: K171497 · 2017-10-12

ApplicantMikron Makina Sanayi Ticaret Co. , Ltd.
Decision Date2017-10-12
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mikron Spinal Fixation System is a medical device manufactured by Mikron Makina Sanayi Ticaret Co. , Ltd.. It received FDA 510(k) clearance on 2017-10-12 under approval number K171497. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mikron Spinal Fixation System?

Mikron Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-10-12. It is manufactured by Mikron Makina Sanayi Ticaret Co. , Ltd.. The 510(k) number is K171497.

When was Mikron Spinal Fixation System approved by the FDA?

Mikron Spinal Fixation System received FDA 510(k) clearance on 2017-10-12, under approval number K171497.

What company makes Mikron Spinal Fixation System?

Mikron Spinal Fixation System is manufactured by Mikron Makina Sanayi Ticaret Co. , Ltd..

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

The FDA product code for Mikron Spinal Fixation System is MNI.

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)

Related Devices (Code: MNI)

K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. K160320PremierShandong Weigao Orthopaedic Device Co., Ltd. K160003Sniper (R) Spine SystemSpine Wave, 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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