Scarlet AL-T— 510(k) K181818

Substantially Equivalent

Spineart

FDA 510(k) clearance K181818 for Scarlet AL-T, Substantially Equivalent on 2018-10-09. Applicant: Spineart.

Clearance details

Applicant: Spineart
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2018-07-09
Decision date: 2018-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plan Les Ouates, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.