Ziehm RFD 3D Tracker— 510(k) K180816
Substantially EquivalentMedtronic Navigation
FDA 510(k) clearance K180816 for Ziehm RFD 3D Tracker, Substantially Equivalent on 2018-07-11. Applicant: Medtronic Navigation. Device class: 2.
Clearance details
- Applicant
- Medtronic Navigation
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, CO, US
Recent devices under product code OLO
view allMore clearances from Medtronic Navigation
view allAdverse 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.