FDA 510(k)

LumFix Spinal Fixation Sytem

K-Number: K160731 · 2016-10-04

Decision Date2016-10-04

Product CodeMNI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LumFix Spinal Fixation Sytem is a medical device manufactured by CG Bio Co., Ltd.. It received FDA 510(k) clearance on 2016-10-04 under approval number K160731. 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 LumFix Spinal Fixation Sytem?

LumFix Spinal Fixation Sytem is a medical device that received FDA 510(k) clearance on 2016-10-04. It is manufactured by CG Bio Co., Ltd.. The 510(k) number is K160731.

When was LumFix Spinal Fixation Sytem approved by the FDA?

LumFix Spinal Fixation Sytem received FDA 510(k) clearance on 2016-10-04, under approval number K160731.

What company makes LumFix Spinal Fixation Sytem?

LumFix Spinal Fixation Sytem is manufactured by CG Bio Co., Ltd..

What is the FDA product code for LumFix Spinal Fixation Sytem?

The FDA product code for LumFix Spinal Fixation Sytem is MNI.

Other Devices by CG Bio Co., Ltd.

K222229Advanced LumFix Spinal Fixation System K250582COLONNADE Posterior Screw Fixation System K252251EASYMADE-TI

Related Devices (Code: MNI)

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. K152324YAHUA Spinal SystemBeijing Weigao Yahua Artificial Joint Development Co. , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.