Renovis A200 PS Knee System as part of the Renovis A200 Knee System— 510(k) K190122
Substantially EquivalentRenovis Surgical Technologies
FDA 510(k) clearance K190122 for Renovis A200 PS Knee System as part of the Renovis A200 Knee System, Substantially Equivalent on 2019-06-20. Applicant: Renovis Surgical Technologies.
Clearance details
- Applicant
- Renovis Surgical Technologies
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redlands, CA, US
Adverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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.