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

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..

Clearance details

Applicant: Spinevision S.A.
Product code: Code MNI
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 ↗

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.