OsteoCoil Nitinol Compression System (Multiple Component PNs)— 510(k) K233567
Substantially EquivalentFlower Orthopedics Corporation Dba Conventus Flower Ortho
FDA 510(k) clearance K233567 for OsteoCoil Nitinol Compression System (Multiple Component PNs), Substantially Equivalent on 2024-11-22. Applicant: Flower Orthopedics Corporation Dba Conventus Flower Ortho. Device class: 2.
Clearance details
- Applicant
- Flower Orthopedics Corporation Dba Conventus Flower Ortho
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Horsham, PA, US
Recent devices under product code HWC
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.