HERA Interlocking Intramedullary Nailing System— 510(k) K253046
Substantially EquivalentZheJiang Decans Medical Devices Co., Ltd.
FDA 510(k) clearance K253046 for HERA Interlocking Intramedullary Nailing System, Substantially Equivalent on 2026-06-16. Applicant: ZheJiang Decans Medical Devices Co., Ltd.. Device class: 2.
Summary
ZheJiang Decans Medical Devices' HERA Interlocking Intramedullary Nailing System is filed under HSB, intramedullary fixation rods and accessories. The record doesn't list the system's components or sizes.
Class II, 21 CFR 888.3020. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Decans filed from Jiaxing, China. The decision came 267 calendar days after FDA received it (September 22, 2025 to June 16, 2026).
Clearance details
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd.
- Product code
- Product code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jiaxing, CN
Recent devices under product code HSB
view allMore clearances from ZheJiang Decans Medical Devices Co., Ltd.
view allAdverse 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.