SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set— 510(k) K191943

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K191943 for SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set, Substantially Equivalent on 2019-10-18. Applicant: Medos International SARL.

Clearance details

Applicant: Medos International SARL
Product code: Code OLO
Advisory panel: Neurology
Date received: 2019-07-22
Decision date: 2019-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lelocle, CH

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.