NavSuite3 Kit— 510(k) K150301
Substantially EquivalentStryker Leibinger GmbH & Co. KG - Navigation
FDA 510(k) clearance K150301 for NavSuite3 Kit, Substantially Equivalent on 2015-07-08. Applicant: Stryker Leibinger GmbH & Co. KG - Navigation.
Clearance details
- Applicant
- Stryker Leibinger GmbH & Co. KG - Navigation
- Product code
- Code HAW
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Freiburg, DE
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . 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.