SkyWalker Total Knee System— 510(k) K213873
Substantially EquivalentMicroport Navibot International, LLC
FDA 510(k) clearance K213873 for SkyWalker Total Knee System, Substantially Equivalent on 2022-07-07. Applicant: Microport Navibot International, LLC.
Clearance details
- Applicant
- Microport Navibot International, LLC
- Product code
- Code OLO
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foxborough, MA, 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.