K242091
Substantially EquivalentBolo Button System
- Applicant
- Fusion Orthopedics
- Product code
- HTN
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mesa, AZ, US
Adverse events under product code HTN
product code HTN- Injury
- 310
- Malfunction
- 639
- Total
- 949
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.