Juliet® Ti LL Lumbar Interbody Device— 510(k) K241321

Substantially Equivalent

Spineart SA

FDA 510(k) clearance K241321 for Juliet® Ti LL Lumbar Interbody Device, Substantially Equivalent on 2024-07-18. Applicant: Spineart SA.

Clearance details

Applicant: Spineart SA
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2024-05-10
Decision date: 2024-07-18
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.