Navigated ELEVATE Inserter, Navigated Disc Prep Instruments— 510(k) K163581
Substantially EquivalentMedtronic Sofamor Danek USA, Inc.
FDA 510(k) clearance K163581 for Navigated ELEVATE Inserter, Navigated Disc Prep Instruments, Substantially Equivalent on 2017-04-14. Applicant: Medtronic Sofamor Danek USA, Inc..
Clearance details
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Product code
- Code OLO
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, 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.