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FDA 510(k)

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System

K-Number: K160124 · 2016-04-04

ApplicantSpinevision S.A.
Decision Date2016-04-04
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Spinevision S.A.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K160124. 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 LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System?

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Spinevision S.A.. The 510(k) number is K160124.

When did LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System receive FDA 510(k) clearance?

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System received FDA 510(k) clearance on 2016-04-04, under 510(k) number K160124.

Who is the listed applicant for LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System?

The FDA 510(k) record lists Spinevision S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System?

The FDA product code for LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System is MNI.

Related Clinical Trials

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.

NCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITING

Other records listing Spinevision S.A. 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.

K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF

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.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International 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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