ZheJiang Decans Medical Devices Co., Ltd.
FDA 510(k) & PMA Approved Devices — 11 products
Total Devices11
Categories9
Latest FDA decision2026-06-16
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253046 | HERA Interlocking Intramedullary Nailing System | HSB | 2026-06-16 | View |
| 510(k) | K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems | NKG | 2026-06-02 | View |
| 510(k) | K252930 | AQUA Laminoplasty Systems | NQW | 2026-05-27 | View |
| 510(k) | K253130 | Dione PEEK Screw System | MBI | 2026-05-27 | View |
| 510(k) | K252776 | ARIES Anterior Cervical Plate Systems | KWQ | 2026-05-14 | View |
| 510(k) | K252542 | LEO Spinal System | NKB | 2026-04-29 | View |
| 510(k) | K253213 | SAGI Cervical Cage System | OVE | 2026-04-20 | View |
| 510(k) | K252774 | Uni-C Cervical Cage System | OVE | 2026-04-15 | View |
| 510(k) | K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) | MBI | 2025-01-31 | View |
| 510(k) | K242195 | Gemini Cervical Fusion Cage System | ODP | 2024-11-04 | View |
| 510(k) | K242267 | Gemini Medical Cage System | MAX | 2024-10-08 | View |
No matching devices.