Kalitec Navigated Instrument System— 510(k) K232572
Substantially EquivalentKalitec Direct, LLC Doing Business AS Kalitec Medical
FDA 510(k) clearance K232572 for Kalitec Navigated Instrument System, Substantially Equivalent on 2023-12-13. Applicant: Kalitec Direct, LLC Doing Business AS Kalitec Medical.
Clearance details
- Applicant
- Kalitec Direct, LLC Doing Business AS Kalitec Medical
- Product code
- Code OLO
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orlando, FL, US
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, 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.