Bendini Cloud Application— 510(k) K233706

Substantially Equivalent

Nuvasive

FDA 510(k) clearance K233706 for Bendini Cloud Application, Substantially Equivalent on 2024-08-02. Applicant: Nuvasive.

Clearance details

Applicant: Nuvasive
Product code: Code OLO
Advisory panel: Neurology
Date received: 2023-11-20
Decision date: 2024-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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.