RENAISSANCE X SYSTEM— 510(k) K140167

Substantially Equivalent

Mazor Robotics , Ltd.

FDA 510(k) clearance K140167 for RENAISSANCE X SYSTEM, Substantially Equivalent on 2014-09-10. Applicant: Mazor Robotics , Ltd..

Clearance details

Applicant: Mazor Robotics , Ltd.
Product code: Code OLO
Advisory panel: Neurology
Date received: 2014-01-23
Decision date: 2014-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

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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.