Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration— 510(k) K200376

Substantially Equivalent

Navbit Pty, Ltd.

FDA 510(k) clearance K200376 for Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration, Substantially Equivalent on 2020-12-10. Applicant: Navbit Pty, Ltd..

Clearance details

Applicant: Navbit Pty, Ltd.
Product code: Code OLO
Advisory panel: Neurology
Date received: 2020-02-18
Decision date: 2020-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crows Nest, AU

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.