SCARLET® AC-Ti— 510(k) K240699

Substantially Equivalent

Spineart SA

FDA 510(k) clearance K240699 for SCARLET® AC-Ti, Substantially Equivalent on 2024-05-10. Applicant: Spineart SA.

Clearance details

Applicant: Spineart SA
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2024-03-14
Decision date: 2024-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plan-Les-Ouates, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.