LEGEND POWER ADAPTER MODEL: 6475000— 510(k) K101168
Substantially EquivalentMedtronic Sofamor Danek
FDA 510(k) clearance K101168 for LEGEND POWER ADAPTER MODEL: 6475000, Substantially Equivalent on 2010-08-24. Applicant: Medtronic Sofamor Danek.
Clearance details
- Applicant
- Medtronic Sofamor Danek
- Product code
- Code HBB
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Adverse events under product code HBB
product code HBB- Malfunction
- 2,656
- Total
- 2,656
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.