HERA Interlocking Intramedullary Nailing System
FDA 510(k) clearance K253046 · decided 2026-06-16
Clearance details
- K-number
- K253046
- Device name
- HERA Interlocking Intramedullary Nailing System
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-22
- Decision date
- 2026-06-16
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Jiaxing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.