Flex-Thread Ulna Intramedullary Nail System— 510(k) K222390
Substantially EquivalentFlower Orthopedics Corporation Dba Conventus Flower
FDA 510(k) clearance K222390 for Flex-Thread Ulna Intramedullary Nail System, Substantially Equivalent on 2022-11-21. Applicant: Flower Orthopedics Corporation Dba Conventus Flower.
Clearance details
- Applicant
- Flower Orthopedics Corporation Dba Conventus Flower
- Product code
- Code HSB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Horsham, PA, US
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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.