The Optimotion Blue Total Knee System— 510(k) K191084
Substantially EquivalentOptimotion Implants, LLC
FDA 510(k) clearance K191084 for The Optimotion Blue Total Knee System, Substantially Equivalent on 2020-04-07. Applicant: Optimotion Implants, LLC.
Clearance details
- Applicant
- Optimotion Implants, LLC
- Product code
- Code MBH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winter Park, FL, US
Adverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
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.