NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS— 510(k) K124004

Substantially Equivalent

Medtronic Navigation, Inc.

FDA 510(k) clearance K124004 for NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS, Substantially Equivalent on 2013-03-22. Applicant: Medtronic Navigation, Inc..

Clearance details

Applicant: Medtronic Navigation, Inc.
Product code: Code OLO
Advisory panel: Neurology
Date received: 2012-12-26
Decision date: 2013-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

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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.