Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LumFix Spinal Fixation Sytem

K-Number: K160731 · 2016-10-04

ApplicantCG Bio Co., Ltd.
Decision Date2016-10-04
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LumFix Spinal Fixation Sytem is the device name listed in this FDA 510(k) record. The listed applicant is CG Bio Co., Ltd.. It received FDA 510(k) clearance on 2016-10-04 under 510(k) 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. The listed applicant is CG Bio Co., Ltd.. The 510(k) number is K160731.

When did LumFix Spinal Fixation Sytem receive FDA 510(k) clearance?

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

Who is the listed applicant for LumFix Spinal Fixation Sytem?

The FDA 510(k) record lists CG Bio Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing CG Bio Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253199CURASYS 2 (EMDN0003)K252251EASYMADE-TIK250582COLONNADE Posterior Screw Fixation SystemK222229Advanced LumFix Spinal Fixation System

Related Devices (Code: MNI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret 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.

↑