Locking Plates and Screws Systems— 510(k) K240958
Substantially EquivalentHebei Ruihe Medical Devices Co., Ltd.
FDA 510(k) clearance K240958 for Locking Plates and Screws Systems, Substantially Equivalent on 2025-02-10. Applicant: Hebei Ruihe Medical Devices Co., Ltd..
Clearance details
- Applicant
- Hebei Ruihe Medical Devices Co., Ltd.
- Product code
- Code HRS
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Shijiazhuang, CN
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.