VEGA Knee System, Columbus Total Knee System— 510(k) K143443
Substantially EquivalentAesculap Implants Systems, LLC
FDA 510(k) clearance K143443 for VEGA Knee System, Columbus Total Knee System, Substantially Equivalent on 2015-03-25. Applicant: Aesculap Implants Systems, LLC.
Clearance details
- Applicant
- Aesculap Implants Systems, LLC
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Center Valley, PA, 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.