LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System— 510(k) K160124

Name: FDA 510(k) clearance K160124
Creator: U.S. Food and Drug Administration
Published: 2016-04-04

Substantially Equivalent

Spinevision S.A.

FDA 510(k) clearance K160124 for LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System, Substantially Equivalent on 2016-04-04. Applicant: Spinevision S.A.. Device class: 2.

Clearance details

Applicant: Spinevision S.A.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2016-01-20
Decision date: 2016-04-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Antony, FR

Download summary PDF View on FDA.gov ↗

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K151458 — Double Medical Universal Spine System2016-08-22
K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
K160320 — Premier2016-04-01

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.