K163565
Substantially EquivalentMR8 Drill System
- Applicant
- Medtronic Powered Surgical Solutions
- Product code
- HBC
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
Adverse events under product code HBC
product code HBC- Malfunction
- 4,715
- Total
- 4,715
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.