Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments— 510(k) K221180
Substantially EquivalentMedtronic Sofamor Danek USA, Inc.
FDA 510(k) clearance K221180 for Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments, Substantially Equivalent on 2022-05-25. 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
- Special
- 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.