Navigated Instrument System— 510(k) K162921

Substantially Equivalent

Orthofix, Inc.

FDA 510(k) clearance K162921 for Navigated Instrument System, Substantially Equivalent on 2017-03-13. Applicant: Orthofix, Inc..

Clearance details

Applicant: Orthofix, Inc.
Product code: Code OLO
Advisory panel: Neurology
Date received: 2016-10-18
Decision date: 2017-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewisville, TX, 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.