K192403
Substantially EquivalentVK100 Percutaneous Vertebral Augmentation System
- Applicant
- Bonwrx, Ltd.
- Product code
- NDN
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lansing, MI, US
Adverse events under product code NDN
product code NDN- Death
- 24
- Injury
- 407
- Malfunction
- 1,975
- Total
- 2,406
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.