SPINEART Navigation Instrument System— 510(k) K241644

Substantially Equivalent

Spineart SA

FDA 510(k) clearance K241644 for SPINEART Navigation Instrument System, Substantially Equivalent on 2024-08-07. Applicant: Spineart SA.

Clearance details

Applicant: Spineart SA
Product code: Code OLO
Advisory panel: Neurology
Date received: 2024-06-07
Decision date: 2024-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Plan-Les-Ouates, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

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.