ZheJiang Decans Medical Devices Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253046 | HERA Interlocking Intramedullary Nailing System | June 16, 2026 |
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | June 2, 2026 |
| K253130 | Dione PEEK Screw System | May 27, 2026 |
| K252930 | AQUA Laminoplasty Systems | May 27, 2026 |
| K252776 | ARIES Anterior Cervical Plate Systems | May 14, 2026 |
| K252542 | LEO Spinal System | April 29, 2026 |
| K253213 | SAGI Cervical Cage System | April 20, 2026 |
| K252774 | Uni-C Cervical Cage System | April 15, 2026 |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ult | January 31, 2025 |
| K242195 | Gemini Cervical Fusion Cage System | November 4, 2024 |
| K242267 | Gemini Medical Cage System | October 8, 2024 |